FrancophonIA/ELRC3.0 huggingface dataset:
English: In 2016, PRAC had considered the findings of meta-analysis of all three studies (RODIN/Pednet, UKHCDO and FranceCoag studies), and again concluded that the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in PUPs.
Maltese: Fl-2016, il-PRAC kien ikkunsidra ssejbiet tal-metaanaliżi tat-tliet studji kollha (l-istudji RODIN/Pednet, UKHCDO u FranceCoag) u għal darb'oħra kkonkluda li l-evidenza li hemm disponibbli attwalment ma tikkonfermax li Kogenate Bayer/Helixate NexGen huwa assoċjat ma' riskju miżjud ta' inibituri tal-fattur VIII, meta mqabbel ma' prodotti tal-fattur VIII rikombinanti oħra f'PUPs.
English: Inhibitors are less likely to occur in previouslytreated patients (PTPs).
Maltese: L-inibituri għandhom inqas probabbiltà li jidhru f'pazjenti li jkunu ġew ikkurati preċedentement (PTPs).
English: Inhibitor rates in these studies range from 15 to 38% for all inhibitors and 9 to 22.6% for high titre inhibitors; i.e. within the range of ‘very common'.
Maltese: Ir-rati tal-inibituri f'dawn l-istudji jvarjaw minn 15 għal 38 % għallinibituri kollha u 9 għal 22.6 % għall-inibituri ta' titre għoli; jiġifieri fil-medda ta' “komuni ħafna”.
English: This included published literature (SIPPET study6), data generated in individual clinical trials and a range of observational studies submitted by the marketing authorisation holders, including the data generated in large multicentre cohort studies, data submitted by the national competent authorities of the EU Member States as well as responses provided by the Authors of the SIPPET study.
Maltese: Din inkludiet letteratura ppubblikata (l-istudju SIPPET6), dejta ġġenerata fi provi kliniċi individwali u medda ta' studji ta' osservazzjoni ppreżentati middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, inkluż id-dejta ġġenerata fi studji ta' koorti multiċentriċi kbar, dejta ppreżentata mill-awtoritajiet nazzjonali kompetenti tal-Istati Membri tal-UE kif ukoll it-tweġibiet ipprovduti mill-Awturi tal-istudju SIPPET.
English: Benefit -risk balance
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju
English: • Finally, the PRAC noted that to date most studies evaluating a differential risk of inhibitor development between classes of FVIII products suffer from a variety of potential methodological limitations and based on the available data considered there is no clear and consistent evidence to suggest differences in relative risk between classes of FVIII products.
Maltese: • Finalment, il-PRAC innota li s'issa ħafna mill-istudji li jevalwaw riskju differenzjali tal-iżvilupp tal-inibituri bejn il-klassijiet ta' prodotti FVIII huma affettwati minn varjetà ta' limitazzjonijiet metodoloġiċi potenzjali u abbażi tad-dejta disponibbli kkunsidra li m'hemm l-ebda evidenza ċara u konsistenti biex tissuġġerixxi differenzi fir-riskju relattiv bejn il-klassijiet ta' prodotti FVIII.
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII
Maltese: L-istudju SIPPET kien prova open-label, randomizzata, multiċentrika, multinazzjonali li tinvestiga linċidenza ta' allo-antikorpi newtralizzanti f'pazjenti b'emofilja A konġenitali severa (konċentrazzjoni ta' FVIII fil-plażma ta' <1%) b'jew l-użu ta' konċentrati pdFVIII jew rFVIII.
English: The available data supports a frequency of FVIII inhibitor development within the frequency of ‘very common' and ‘uncommon', for PUPs and PTPs respectively, therefore the PRAC recommends that the SmPCs should be aligned with these frequencies unless justified by product specific data.
Maltese: Id-dejta disponibbli tappoġġja frekwenza tal-iżvilupp tal-inibitur FVIII filfrekwenza ta' “komuni ħafna” u “mhux komuni” għall-PUPs u għall-PTPs rispettivament, għalhekk il-PRAC jirrakkomanda li l-SmPCs għandhom jiġu allinjati ma' dawn il-frekwenzi sakemm ma jiġix iġġustifikat minn dejta speċifika għall-prodott.
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Maltese: Il-kura b'kemm pdFVIII kif ukoll b'rFVIII tista' twassal għall-iżvilupp tal-inibituri (ittestjat bil-metodu ta' Nijmegen tal-assaġġ Bethesda u definit bħala ≥0.6 unitajiet Bethesda (BU, Bethesda units) għal inibitur ta' “titre baxx” u >5 BU għal inibitur ta' “titre għoli”).
English: The findings from the SIPPET study, as well as those from the individual clinical trials and observational studies, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between the rFVIII and pdFVIII product classes.
Maltese: Is-sejbiet mill-istudju SIPPET, kif ukoll dawk mill-provi kliniċi individwali u millistudji ta' osservazzjoni, mhumiex biżżejjed biex jikkonfermaw xi differenza statistikament konsistenti u klinikament sinifikanti fir-riskju ta' inibituri bejn klassijiet tal-prodotti rFVIII u pdFVIII.
English: VWF is not present in rFVIII, but there is significant heterogeneity within the rFVIII class for instance due to the different manufacturing processes used, with a wide range of products from different manufacturers produced over the past 20 years.
Maltese: VWF mhuwiex preżenti f'rFVIII, iżda hemm eteroġeneità sinifikanti fil-klassi rFVIII, pereżempju, minħabba l-proċessi differenti ta' manifattura li jintużaw, b'medda vasta ta' prodotti minn manifatturi differenti prodotti matul l-aħħar 20 sena.
English: With regards to sections 4.8 and 5.1, the PRAC noted that several FVIII products currently include reference to data from study results which do not allow a definite conclusion on the inhibitor risk for individual products.
Maltese: Fir-rigward tas-sezzjonijiet 4.8 u 5.1, il-PRAC innota li diversi prodotti FVIII bħalissa jinkludu referenza għal dejta minn riżultati tal-istudju li ma jippermettux konklużjoni definita dwar ir-riskju ta' inibituri għal prodotti individwali.
English: This trial, known as the SIPPET study (“Survey of Inhibitors in Plasma-Product Exposed Toddlers”) was conducted to evaluate the relative risk of inhibitors in patients treated with pdFVIII compared to rFVIII.
Maltese: Din il-prova, magħrufa bħala l-istudju SIPPET (“Stħarriġ ta' Inibituri fi Trabi li telqu jimxu Esposti għal Prodotti tal-Plażma, Survey of Inhibitors in Plasma-Product Exposed Toddlers”) saret biex tevalwa r-riskju relattiv tal-inibituri f'pazjenti kkurati b'pdFVIII meta mqabbel ma' rFVIII.
English: The experts also agreed that the degree of immunogenicity of different products was adequately described overall with the amendments to the SmPC proposed by the PRAC highlighting the clinical relevance of inhibitor development (in particular low compared to high titre inhibitors), as well as the frequency of ‘very common' in PUPs and ‘uncommon' in PTPs.
Maltese: L-esperti qablu wkoll li l-grad tal-immunoġeniċità ta' prodotti differenti ġie deskritt b'mod adegwat globalment mal-emendi għall-SmPC proposti mill-PRAC li jenfasizzaw ir-relevanza klinika tal-iżvilupp tal-inibituri (b'mod partikolari inibituri ta' titre baxx meta mqabbla ma' ta' titre għoli), kif ukoll ilfrekwenza ta' “komuni ħafna” f'PUPs u “mhux komuni” f'PTPs.
English: • The section 4.4 of the SmPC should be amended to include a warning on the clinical importance of monitoring patients for FVIII inhibitor development (in particular warning on the clinical consequences of low compared to high titre inhibitors).
Maltese: • Is-sezzjoni 4.4 tal-SmPC għandha tiġi emendata biex tinkludi twissija dwar l-importanza klinika tal-monitoraġġ tal-pazjenti għall-iżvilupp tal-inibituri FVIII (b'mod partikolari twissija dwar ilkonsegwenzi kliniċi ta' inibituri ta' titre baxx meta mqabbla ma' ta' titre għoli).
English: PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for re-examination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Maltese: Il-PRAC ikkunsidra wkoll ir-raġunijiet ippreżentati minn LFB Biomedicaments bħala bażi għat-talba tagħhom għal eżaminazzjoni mill-ġdid tar-rakkomandazzjoni tal-PRAC u l-fehmiet ta' żewġ laqgħat ta' esperti li saru fit-22 ta' Frar u fit-3 ta' Awwissu 2017.
English: The SIPPET study
Maltese: L-istudju SIPPET
English: Published observational studies
Maltese: Studji ta' osservazzjoni ppubblikati
English: This association was consistently observed in multivariable analysis.
Maltese: Din l-assoċjazzjoni ġiet osservata b'mod konsistenti f'analiżi multivarjabbli.
English: It is uncertain whether the findings of SIPPET can be extrapolated to the risk of inhibitors in PUPs in current clinical practice in the EU as treatment modality and intensity have been suggested as risk factors for inhibitor development in previous studies.
Maltese: Hemm inċertezza dwar jekk is-sejbiet ta' SIPPET jistgħux jiġu estrapolati għarriskju tal-inibituri f'PUPs fil-prattika klinika attwali fl-UE peress li, fi studji preċedenti, ilmodalità u l-intensità tal-kura ġew issuġġeriti bħala fatturi ta' riskju għall-iżvilupp tal-inibituri.
English: Further to the assessment of the totality of the responses submitted by the MAH for susoctocog alfa (Obizur), the PRAC is of the opinion that the outcome of this article 31 referral procedure does not apply to this product in view of the indication of Obizur (acquired haemophilia A due to inhibitory antibodies to endogenous FVIII) and the different target population.
Maltese: Wara l-valutazzjoni tat-totalità tat-tweġibiet ippreżentati mill-MAH għal susoctocog alfa (Obizur), ilPRAC huwa tal-opinjoni li l-eżitu ta' din il-proċedura ta' referenza tal-Artikolu 31 ma japplikax għal dan il-prodott fid-dawl tal-indikazzjoni ta' Obizur (emofilja A akkwiżita minaħbba antikorpi inibitorji għal FVIII endoġenu) u l-popolazzjoni fil-mira differenti.
English: Many of these studies were small and not specifically designed to evaluate the inhibitor risk in PUPs with severe haemophilia A. The studies were mostly single arm and do not provide data to perform comparative analysis (either between pdFVIII and rFVIII as a class comparison, or within the rFVIII class).
Maltese: L-istudji kienu l-aktar ta' fergħa waħda u ma pprovdewx dejta biex iwettqu analiżi komparattiva (jew bejn pdFVIII u rFVIII bħala tqabbil bejn il-klassi, jew fil-klassi rFVIII).
English: ATC vet code: QI07AJ06.
Maltese: QI07AJ06.
English: Suspension (inactivated) : L. interrogans serovar Icterohaemorrhagiae
Maltese: Sospensjoni (inattivat): L.interrogans serovar Icterohaemorrhagiae
English: 50 x 1 dose
Maltese: 50 x 1 doża
English: Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70
Maltese: Trometamol Edetic Acid Sucrose
English: PACKAGE SIZE 25 x 1 dose
Maltese: DAQS TAL-PAKKETT 25 x 1 doża
English: Canine parainfluenza virus Type 2
Maltese: Canine parainfluenza virus tip 2
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/2014.
Maltese: Data tal-ewwel awtorizzazzjoni: 07/05/2014.
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus and rabies.
Maltese: Tal-anqas tliet snin wara l-kors primarju għall-canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus u rabbja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/163/001
Maltese: FIS-SUQ EU/2/14/163/001
English: However, in field studies 10% of sero-negative dogs did not show seroconversion (> 0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Maltese: Mandankollu, f'field studies 10% ta' klieb sero-negattivi ma serokonverżjoni (> 0.1 IU/ml) 3-4 ġimgħat wara doża primarja waħda kontra r-rabbja.
English: Two doses of Versican Plus DHPPi/L4R 3-4 weeks apart from 8-9 weeks of age.
Maltese: Żewġ dożi ta' Versican Plus DHPPi/L4R 3-4 ġimgħat minn xulxin minn età ta' 8-9 ġimgħat.
English: Pharmacotherapeutic group: Immunologicals for canidae, live and inactivated viral and inactivated bacterial vaccines.
Maltese: Immunoloġiċi għal canidae, vaċċini virali ħajjin u inattivati u vaċċini batteriċi inattivati.
English: Aluminium hydroxide
Maltese: Idrossidu tal-aluminju
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
Maltese: It-tilqima hija intenzjonata għall-immunizzazzjoni attiva fi ġriewi f'saħħithom u klieb kontra mard ikkawżat mill-virus tal-canine distemper, mill-canine parvovirus, mill-canine adenovirus tip 1 and 2, millcanine parainfluenza virus, mill-Leptospira interrogens serogrupp Australis serovar Bratislava,
English: Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years.
Maltese: Rispons immunitarju protettiv għal mard respiratorju assoċċjat mal-CAV-2 huwa kkunsidrat li jdum tal anqas tliet snin.
English: Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih 1 ml sospensjoni magħluqa b'tapp tal-lastiku chlorobutyl u kappa talaluminju.
English: Shake well and administer immediately the entire content (1 ml) of the reconstituted product.
Maltese: Ħallat sew u immedjatament amministra l kontenut kollu (1 ml) tal-prodott rikostitwit.
English: Active immunisation of dogs from 8-9 weeks of age: - to prevent mortality and clinical signs caused by canine distemper virus, - to prevent mortality and clinical signs caused by canine adenovirus type 1, - to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2, - to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, - to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus, - to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup
Maltese: Tilqim attiv għal klieb minn età ta' 8-9 ġimgħat: - biex tilqa' għal mortalità u sinjali kliniċi kkawżati mill-canine distemper virus, - biex tilqa' għal mortalità u sinjali kliniċi kkawżati mill-canine adenovirus tip 1, - biex tilqa' għas-sinjali kliniċi u tixrid virali kkawżati mill-canine adenovirus tip 2, - biex tilqa' għas-sinjali kliniċi, lewkopinja u tixrid virali kkawżati mill-canine parvo virus, - biex tilqa' għas-sinjali kliniċi (tnixxija mill-imnieħer u l-għajnejn) u tnaqqas it-tixrid virali kkważat mill-canine parainfluenza virus, - biex tilqa' għas-sinjali kliniċi, infezzjoni u tixrid mal-urina kkawżat minn L.interrogens serogrupp
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R lyophilisate for dogs
Maltese: Versican Plus DHPPi/L4R Lijofiliżat għall-klieb
English: Therefore, the first dose may be given using Versican Plus DHPPi/L4.
Maltese: Għalhekk l-ewwel doża tista' tingħata bl-użu ta' Versican Plus DHPPi/L4.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R suspension for dogs
Maltese: Versican Plus DHPPi/L4R sospensjoni għall-klieb
English: Australis serovar Bratislava, - to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, - to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and - to prevent mortality, clinical signs and infection caused by rabies virus.
Maltese: Icterohaemorrhagiae, - biex tilqa' għas-sinjali kliniċi u tnaqqas l-infezzjoni u tixrid mal-urina kkawżati minn L. kirschneri serogrupp Grippotyphosa serovar Grippotyphosa u - biex tilqa' għall-mortalità, sinjali kliniċi u infezzjoni kkawżati mill-virus tar-rabbja.
English: PACKAGE LEAFLET: Versican Plus DHPPi/L4R lyophilisate and suspension for suspension for injection for dogs
Maltese: Versican Plus DHPPi/L4R lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni għall-klieb
English: Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after the first vaccination for CDV, CAV, CPV, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after completion of the primary course for Leptospira components.
Maltese: - Ġimagħtejn wara tilqima waħda minn età ta' 12-il ġimgħa għar-rabbja. - 3 ġimgħat wara l-ewwel tilqima għal CDV, CAV, CPV. - 3 ġimgħat wara li jintemm il-kors primarju għal CpiV, u - 4 ġimgħat wara li jintemm il-kors primarju għall-komponenti tal-Leptospira.
English: The live attenuated virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated dogs following vaccination, shedding of CPV has been shown for up to 10 days.
Maltese: L-istrejn attenwati ħajjin mill-vaċċin tal-virus CAV-2, CPiV u CPV-2b jistgħu jinxterdu mill-klieb mlaqqma wara t-tilqima, tixrid ta' CPV deher sa 10 ijiem.
English: Primary vaccination scheme:
Maltese: Kodiċi ATC veterinarja:
English: Disposal: read package leaflet.
Maltese: DIKJARAZZJONI TAL -MRLs Mhux applikabbli.
English: The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
Maltese: L-istrejn tal-virus CPV-2b tal-vaċċin ma ġiex ittestjat fuq u karnivori oħra (ħlief klieb u qtates domestiċi) li hu magħruf li huma suxxettibbli għall-canine parvoviruses u għalhekk klieb imlaqqma għandhom jiġu sseparati minnhom wara t-tilqima.
English: At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Maltese: Tal-anqas sena wara l-kors primarju għall-CPiV u għall-komponenti tal-Leptospira.
English: Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih doża waħda ta' lijofiliżat magħluqa b'tapp tal-bromobutyl rubber u kappa tal-aluminju.
English: Annual re-vaccination is required for Parainfluenza and Leptospira components therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Maltese: Hemm bżonn ta' tilqima repetuta kull sena għall-Parainfluenza u għall-komponenti tal-Leptospiragħalhekk doża waħda talvaċċin kompatibbli Versican Plus Pi/L4R tista' tingħata kull sena skont il-bżonn.
English: EU/1/08/498/002 EU/1/08/498/003 EU/1/08/498/005 EU/1/08/498/006 EU/1/08/498/007 EU/1/08/498/008
Maltese: EU/1/08/498/002 EU/1/08/498/003 EU/1/08/498/005
English: How to switch from an antidepressant medicine (SSRI/SNRI) to Thymanax?
Maltese: Kif taqleb minn mediċina antidipressanti (SSRI/SNRI) għal Thymanax?
English: [EU/1/08/498/002] 14 film-coated tablets [EU/1/08/498/003] 28 film-coated tablets [EU/1/08/498/005] 56 film-coated tablets [EU/1/08/498/006] 84 film-coated tablets [EU/1/08/498/007] 98 film-coated tablets [EU/1/08/498/008] 100 film-coated tablets
Maltese: [EU/1/08/498/002] 14-il pillola miksija b'rita [EU/1/08/498/003] 28 pillola miksija b'rita [EU/1/08/498/005] 56 pillola miksija b'rita [EU/1/08/498/006] 84 pillola miksija b'rita [EU/1/08/498/007] 98 pillola miksija b'rita [EU/1/08/498/008] 100 pillola miksija b'rita
English: INFORMATION IN BRAILLE Thymanax 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Thymanax 25 mg
English: How to take THYMANAX
Maltese: Tiħux Thymanax
English: Thymanax is indicated for the treatment of major depressive episodes in adults.
Maltese: Thymanax huwa indikat għall-kura ta' episodji dipressivi maġġuri f'adulti.
English: In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were seen from 125 mg/kg/day whereas in monkeys the induction was slight for CYP2B and CYP3A at 375 mg/kg/day.
Maltese: F'annimali li jgerrmu, induzzjoni qawwija ta' CYP2B u induzzjoni moderata ta' CYP1A u CYP3A dehru minn 125 mg/kg/kuljum waqt li fix-xadini, l-induzzjoni kienet ftit għal CYP2B u CYP3A bi 375 mg/kg/kuljum.
English: Date of latest renewal: 7 January 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Frar 2009 Data tal-aħħar tiġdid: 7 ta' Jannar 2019
English: Thymanax contains the active ingredient agomelatine.
Maltese: Thymanax fih is-sustanza attiva agomelatine.
English: What Thymanax contains - The active substance is agomelatine.
Maltese: X'fih Thymanax - Is-sustanza attiva hi agomelatine.
English: Thymanax is used in adults.
Maltese: Thymanax jintuża fl-adulti.
English: Thymanax 25 mg film-coated tablets agomelatine
Maltese: Thymanax 25 mg pilloli agomelatine
English: Servier Polska Sp. z o.o.
Maltese: Servier Pharma d. o. o.
English: In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo (see section 4.2).
Maltese: Fi provi kliniċi fost tfal u adoloxxenti kkurati b'antidipressanti oħra, imġiba relatata mas-suwiċidju (attentati suwiċidali u ħsibijiet ta' suwiċidju), u ostilità (l-aktar aggressjoni, imġiba konfrontali u rabja) kienu osservati iktar frekwenti meta mqabbla ma dawk li kienu kkurati bil-plaċebo (ara sezzjoni 4.2).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Servier (Ireland) Industries Ltd
Maltese: Servier (Ireland) Industries Ltd
English: Thymanax contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Thymanax fih inqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment “mingħajr sodium”.
English: Thymanax contains lactose
Maltese: Thymanax fih lactose
English: Consequently, co-administration of Thymanax with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Maltese: korriment tal-fwied u interazzjonijiet ma' inibituri qawwijin tas-CYP1A2 (eż. fluvoxamine, ciprofloxacin);
English: You should not take Thymanax together with certain medicines (see also under “Do not take Thymanax” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood.
Maltese: M'għandekx tieħu Thymanax flimkien ma' ċertu mediċini (ara wkoll taħt ‘Tiħux Thymanax' f'sezzjoni 2): fluvoxamine (mediċina oħra użata biex tikkura d-dipressjoni), ciprofloxacin (antibijotiku) jistgħu jbiddlu ddoża mistennija ta' agomelatine fid-demm tiegħek.
English: Thymanax 25 mg film-coated tablets are available in calendar blisters.
Maltese: Thymanax 25 mg pilloli miksija b'rita huma disponibbli f'folji b'kalendarju.
English: What is in this leaflet:
Maltese: Jista' jkun hemm xi raġunijiet għala Thymanax ma jkunx jaqbel miegħek:
English: Thymanax contains lactose.
Maltese: Thymanax fih il-lactose.
English: Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution.
Maltese: epatiku; isoenżimi CYP2C9 u CYP2C19 huma wkoll involuti imma b'kontribuzzjoni baxxa.
English: What Thymanax looks like and contents of the pack Thymanax 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo'
Maltese: Kif jidher Thymanax u l-kontenut tal-pakkett Thymanax 25 mg pilloli miksija b'rita (pillola) huma rettangolari, oranġjo fl-isfar bil-logo tal-kumpanija mnaqqax bil-blu fuq naħa minnhom.
English: (>3 times the upper limit of the normal range) Hepatic failure*(1)
Maltese: Żieda fl-alkaline phosphatase* (>3 darbiet mill-ogħla limitu tal-firxa normali) Indeboliment tal-fwied*(1) Suffejra*