FrancophonIA/ELRC3.0 huggingface dataset:
English: Several risk minimisation activities (such as restriction of the indication, recommendation of only short term treatment, supply of only small package and change of the prescription category to a more restrictive) have been proposed by the MAHs.
Maltese: Diversi attivitajiet tat-tnaqqis tar-riskju (bħar-restrizzjoni ta' l-indikazzjoni, ir-rakkomandazzjoni ta' trattament għal perjodu qasir biss, il-fornitura ta' pakkett żgħir biss u l-bdil tal-kategorija talpreskrizzjoni għal waħda iktar restrittiva) ġew proposti mill-MAHs.
English: The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting.
Maltese: Il-proċedura skond l-Artikolu 107(2) tad-Directtiva 2001/83/KE, kif emendata nbdiet fil-laqgħa tas-CHMP ta' Settembru ta' l-2007.
English: In its assessment NoMA concluded that carisoprodol was associated with an increased risk of abuse or addiction, intoxication and events related to psychomotor impairment.
Maltese: Fil-valutazzjoni tagħha, in-NoMA kkonkludiet li carisoprodol kien assoċjat ma' żieda fl-abbuż jew fid-dipendenza, intossikazzjoni u avvenimenti relatati ma' problemi psikometriċi.
English: The lack of recent safety studies comparing carisoprodol to other analgesic products with a better studied safety profile available for the same indication emphasizes the need for further systematic investigation.
Maltese: In-nuqqas ta' studji dwar is-sigurtà riċenti li jqabblu carisoprodol ma' prodotti analġeżiċi oħra bi profil tas-sigurtà studjat aħjar disponibbli għall-istess indikazzjoni jenfasizza li hemm bżonn isiru iktar investigazzjonijiet sistematiċi.
English: There is available evidence that carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Maltese: Hemm evidenza li carisoprodol huwa assoċjat ma' riskju ta' abbuż, problemi psikometriċi u intossikazzjoni.
English: The serum concentrations for carisoprodol together with the pharmacodynamic results on somnolence found in this study clearly confirmed the Norwegian observational study results that there should be strong warnings against the use of motor vehicle due to somnolence when using carisoprodol medication.
Maltese: Barra minn hekk hemm tagħrif dwar rapporti spontanji kif ukoll rapporti minn ċentri dwar is-sustanzi velenużi fl-Ewropa u fl-Istati Uniti li hemm problemi ta' intossikazzjonijiet.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: The MAHs of carisoprodol containing products have not provided any sound clinical data, which would demonstrate the efficacy of carisoprodol.
Maltese: Il-MAHs ta' prodotti li fihom carisoprodol ma pprovvdew l-ebda tagħrif kliniku affidabbli li juri l-effikaċja ta' carisoprodol.
English: They include tablets and supositories available under prescription in 12 EU Member States.
Maltese: Dawn jinkludu pilloli u suppożitorji disponibbli b'riċettta ta' tabib fi 12-il Stat Membru ta' l-UE.
English: GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
Maltese: U RAĠUNIJIET GĦAS-SOSPENSJONI TA' LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ IPPREŻENTATI
English: As pharmacological studies with carisoprodol have been limited to single dose studies, there have been some uncertainties to the mechanism for the observed effects of carisoprodol and whether they are associated with carisoprodol itself or with its metabolites.
Maltese: Billi l-istudji farmakoloġiċi ma' carisoprodol ġew limitati għal studji dwar doża waħda, kien hemm inċertezzi dwar il-mekkaniżmu għall-effetti osservati ta' carisoprodol u jekk humiex assoċjati ma' carisoprodol innifsu jew mal-metaboliti tiegħu.
English: Furthermore the CHMP took note that there are other effective medications with a more favourable safety profile for the treatment of acute low back pain.
Maltese: Barra minn hekk is-CHMP ħa nota li hemm mediċini oħra effettivi bi profil tas-sigurtà iktar favorevoli għat-trattament ta' l-uġigħ fin-naħa t'isfel tad-dahar.
English: There are several scientific publications analysing the adverse effects of intoxication and psychomotor impairment.
Maltese: Hemm ħafna pubblikazzjonijiet xjentifiċi li janalizzaw l-effetti ħżiena ta' lintossikazzjoni u l-problemi psikometriċi.
English: The study gave support to earlier work published on the impairing effects of carisoprodol.
Maltese: L-istudju appoġġja x-xogħol preċedenti ppubblikat dwar il-problemi psikometriċi ta' carisoprodol.
English: Thus the CHMP recommended the suspension of the Marketing Authorisations for all carisoprodol containing medicinal products listed in Annex I. For the suspension to be lifted the Marketing Authorisation Holders would need to provide:
Maltese: Barra minn hekk hemm dejta minn ċentri għall-prodotti velenużi li tikkonferma dan it-tħassib.
English: The Committee considered that the efficacy of carisoprodol containing products is poorly documented; only three relatively old studies are available to demonstrate efficacy in acute low back pain.
Maltese: Il-Kumitat ikkunsidra li l-effikaċja ta' prodotti li fihom carisoprodol hija ddokumentata b'mod fqir; huma disponibbli biss tliet studji relattivament antiki li juru l-effikaċja fl-uġigħ fin-naħa t'isfel taddahar.
English: London, 18 March 2009 Doc.
Maltese: Londra, 18 ta' Marzu 2009 Dok. ta' Ref.
English: Ref. EMEA/CHMP/204584/2009
Maltese: EMEA/202996/2009
English: Tritazide can also be available in the EU and the EEA under other trade names: Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite,Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark..
Maltese: Tritazide jista' jkun disponibbli wkoll fl-UE u fiż-ŻEE taħt ismijiet kummerċjali oħra: Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, u Triatec Comp Mite,Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark.
English: TRITAZIDE (see section 4.4)
Maltese: TRITAZIDE (ara sezzjoni 4.4)
English: Tritazide has been authorised in the EU since 1993, first in Germany and then in the following countries: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Maltese: Tritazide ilu awtorizzat fl-UE sa mill-1993, l-ewwel fil-Ġermanja u mbagħad fil-pajjiżi li ġejjin: flAwstrija, fil-Belġju, fil-Bulgarija, f'Ċipru, fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, filFinlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Ungerija, fl-Irlanda, fl-Italja, fil-Lussemburgu, flOlanda, fil-Polonja, fil-Portugall, fir-Rumanija, fis-Slovakja, fis-Slovenja, u fl-Iżvezja.
English: Hydrochlorothiazide (HCTZ) is a diuretic.
Maltese: Hydrochlorothiazide (HCTZ) huwa dijuretiku.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, referenza abbażi ta' deċiżjonijiet diverġenti adottati millIstati Membri fejn jiġi kummerċjalizzat il-prodott.
English: What is Tritazide?
Maltese: X'inhu Tritazide?
English: The company that markets Tritazide is Sanofi-aventis.
Maltese: Il-kumpanija li tikkummerċjalizza Tritazide hija Sanofi-aventis.
English: • Treatment of hypertension
Maltese: • Kura ta' ipertensjoni
English: The combination ramipril 2.5 mg/ HCTZ 12.5 mg led to greater reduction in blood pressure than the treatment with individual components and the combination of 5 mg/25 mg produced a better therapeutic effect than doubling the ramipril dose to 10 mg.
Maltese: Il-kombinazzjoni ta' ramipril 2.5 mg/ HCTZ 12.5 mg wasslet għal tnaqqis akbar fil-pressjoni taddemm milli l-kura b'komponenti individwali u l-kombinazzjoni ta' 5 mg/25 mg ipproduċiet effett terapewtiku aħjar mill-irduppjar tad-doża ta' ramipril għal 10 mg.
English: The CHMP included also new warnings for: pregnancy, surgery, electrolyte disturbances, and cough.
Maltese: Is-CHMP inkluda wkoll twissijiet ġodda għal: tqala, intervent kirurġiku, disturbi elettrolitiċi u sogħla.
English: • Severe impairment of renal function with a creatinine clearance below 30 ml/min in undialysed patients
Maltese: • Indeboliment qawwi tal-funzjoni renali bit-tneħħija ta' kreatinina taħt it-30 ml/min f'pazjenti li mhumiex dijalizzati
English: • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
Maltese: • Stenożi tal-arterja renali bilaterali sinifikanti jew stenożi tal-arterja renali f'kilwa waħda funzjonanti
English: Tritazide contains two active substances, ramipril and hydrochlorothiazide.
Maltese: Tritazide fih żewġ sustanzi attivi, ramipril u hydrochlorothiazide.
English: Tritazide tablets containing ramipril and hydrochlorothiazide
Maltese: Tritazide li fihom ramipril u hydrochlorothiazide
English: Ramipril is an angiotensin converting enzyme (ACE) inhibitor.
Maltese: Ramipril huwa inibitur tal-enzima li tikkonverti l-anġjotensina (ACE).
English: Company responses provided on: 28 April 2008, 24 October 2008 Opinion date:
Maltese: Tweġibiet tal-kumpanija pprovduti nhar: 28 ta' April 2008, 24 ta' Ottubru 2008
English: • Clinically relevant electrolyte disturbances which may worsen following treatment with
Maltese: • Disturbi elettrolitiċi klinikament rilevanti li jistgħu jmorru għall-agħar wara kura bi
English: Tritazide has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Tritazide ġie identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproċi u Deċentralizzati - Bniedem (CMD(h)).
English: The CHMP noted inconsistencies in the wording of the indication across countries, with terms including ‘essential hypertension', ‘arterial hypertension' and ‘arterial essential hypertension' being used.
Maltese: Is-CHMP innota inkonsistenzi fil-kliem tal-indikazzjoni madwar il-pajjiżi, bl-użu ta' termini li jinkludu ‘ipertensjoni essenzjali', ‘ipertensjoni arterjali' u ‘ipertensjoni essenzjali arterjali'.
English: The CHMP adopted the harmonised wording:
Maltese: Is-CHMP adotta l-kliem armonizzat:
English: The European Medicines Agency (EMEA) has completed a review of Tritazide.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet reviżjoni ta' Tritazide.
English: inhibitors or AIIRAs(Angiotensin II Receptor Antagonists))
Maltese: • Passat ta' anġjoedema (ereditarja, idjopatika jew dovuta għal anġjodema preċedenti b'inibituri ACE jew AIIRAs (Antagonisti tar-Riċettur tal-Angjotensina II - Angiotensin II Receptor Antagonists))
English: • Lactation (see section 4.6)
Maltese: • Treddigħ (ara sezzjoni 4.6)
English: The CHMP endorsed the current list of products which interact or may interact with Tritazide, including additional text reinforcing lithium toxicity.
Maltese: Is-CHMP approva l-lista attwali ta' prodotti li ma jaqblux jew li jistgħu jinteraġixxu ma' Tritazide, inkluż test addizzjonali li jirrinforza t-tossiċità tal-litju.
English: The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Maltese: Id-doża għandha tkun individwalizzata skont il-profil tal-pazjent (ara sezzjoni 4.4) u l-kontroll talpressjoni tad-demm.
English: Tritazide is authorised in the European Union (EU) via national procedures.
Maltese: Tritazide huwa awtorizzat fl-Unjoni Ewropea (UE) permezz ta' proċeduri nazzjonali.
English: The CHMP discussed the areas where there was a divergence identified in the dose recommendations.
Maltese: Is-CHMP iddiskuta l-oqsma fejn ġiet identifikata diverġenza fir-rakkomandazzjonijiet tad-dożi.
English: • Severe impairment of liver function, hepatic encephalopathy
Maltese: • Indeboliment qawwi tal-funzjoni tal-fwied, enċefalopatija epatika
English: The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.
Maltese: L-amministrazzjoni tal-kombinazzjoni fissa ta' ramipril u hydrochlorothiazide hija normalment irrakkomandata wara titrazzjoni b'wieħed mill-komponenti individwali.
English: If ramipril + hydrochlorothiazide is used in a patient with primary hyperaldosteronism, then careful monitoring of plasma potassium level is required.
Maltese: Jekk ramipril + hydrochlorothiazide jintuża f'pazjent b'iperaldosteroniżmu primarju, ikun meħtieġ monitoraġġ preċiż tal-livell tal-potassju filplażma.
English: The CHMP highlighted that fact that the indication should be hypertension, and as add-on therapy when each monotherapy has failed.
Maltese: Is-CHMP enfasizza l-fatt li l-indikazzjoni għandha tkun ipertensjoni, u bħala kura addizzjonali meta kull monoterapija tkun falliet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritazide in the European Union and the European Economic Area (EEA).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li hemm ħtieġa li linformazzjoni tal-preskrizzjoni għal Tritazide tkun armonizzata fl-Unjoni Ewropea (UE) u fiż-Żona Ekonomika Ewropea (ŻEE).
English: The CHMP also noted that there were limited trial data regarding titration steps with the combination.
Maltese: Is-CHMP innota wkoll li kien hemm dejta limitata dwar il-provi rigward il-passi tat-titrazzjoni bil-kombinazzjoni.
English: If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.
Maltese: Jekk ikun meħtieġ, iddoża tista' tiżdied bil-mod il-mod biex wieħed jilħaq il-pressjoni tad-demm mixtieqa; id-dożi massimi permessi huma ta' 10 mg ta' ramipril u 25 mg ta' hydrochlorothiazide kuljum.
English: Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications:
Maltese: Meta wieħed jikkunsidra li ma jista' jiġi stabbilit l-ebda tħassib kbir rigward is-sigurtà, l-effikaċja u lavveniment kliniku avvers tal-kombinazzjoni ta' ramipril/HCTZ f'dawk li ma jirreaġixxux għal HCTZ u ramipril waħedhom, is-CHMP adotta ż-żewġ frażijiet armonizzati li ġejjin għal indikazzjonijiet:
English: The majority of the contraindications are related to use of ramipril as a component of Tritazide.
Maltese: Il-parti l-kbira tal-kontraindikazzjonijiet huma marbutin mal-użu ta' ramipril bħala komponent ta' Tritazide.
English: They are extended with the contraindications of HCTZ.
Maltese: Dawn huma estiżi bil-kontraindikazzjonijiet ta' HCTZ.
English: This is in line with the recommendation of the CHMP's Pharmacovigilance Working Party on use of ACE inhibitors in pregnancy.
Maltese: Dan sar b'konformità mar-rakkomandazzjoni tal-Grupp ta' Ħidma Farmakoviġilanti tas-CHMP dwar l-użu ta' inibituri ACE waqt it-tqala.
English: The CHMP included under this session the warning about primary hyperaldosteronism, therefore adopted the following harmonised wording: The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
Maltese: Il-kombinazzjoni ramipril + hydrochlorothiazide ma tirrappreżentax kura ta' għażla għall-iperaldosteroniżmu primarju.
English: Why was Tritazide reviewed?
Maltese: Għaliex ġie rivedut Tritazide?
English: Applicant company name, address
Maltese: Isem tal-kumpanija, indirizz
English: United Kingdom Hetero Europe S.L.
Maltese: Mnjen jingħata
English: Invented Name
Maltese: Anness I
English: Catalunya 83-85
Maltese: Ir-Renju Unit
English: Viladecans Business
Maltese: Il-Ġermanja
English: End of December 2018
Maltese: L-aħħar ta' Diċembru 2018
English: For chlormadinone-containing combined hormonal contraceptives The MAHs for chlormadinone containing CHCs should carry out a post-authorisation safety study to compare the risk of VTE with chlormadinone/ethinyestradiol versus levonorgestrel/ethinyestradiol.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għal CHCs li fihom chlormadinone għandhom iwettqu studju dwar is-sigurtà wara l-awtorizzazzjoni biex iqabblu r-riskju ta' VTE b'chlormadinone/ethinylestradiol kontra levonorgestrel/ethinylestradiol.
English: The protocol of this study should be submitted to the PRAC within 6 months after notification of the EC Decision.
Maltese: Il-protokoll ta' dan l-istudju għandu jiġi ppreżentat lill-PRAC fi żmien 6 xhur wara n-notifika tad-Deċiżjoni tal-KE.
English: National Competent Authorities of Member States or Reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Maltese: Kondizzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri jew tal-Istati Membri ta' Referenza, jekk applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mill-MAHs:
English: The final study report should be submitted by:
Maltese: Ir-rapport finali tal-istudju għandu jiġi ppreżentat sa:
English: Conditions to the marketing authorisations
Maltese: Kondizzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq
English: The full EPAR for Memantine 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: The active substance in Memantine Mylan, memantine, is an antidementia medicine.
Maltese: Is-sustanza attiva Memantine Mylan, il-memantina, hija mediċina kontra d-dimenzja.
English: From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Mir-raba' ġimgħa 'l quddiem id-doża rakkomandata tinżamm 20 mg darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Memantine Mylan.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Memantine Mylan.
English: Memantine Mylan is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Maltese: Memantine Mylan jiġi f'pilloli ta' 10 mg u 20 mg u jista jinkiseb biss b'riċetta ta' tabib.
English: Memantine Mylan memantine
Maltese: Kif jintuża Memantine Mylan?
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Maltese: In-newrotrażmettituri huma sustanzi kimiċi fis-sistema nervuża li jippermettu liċ-ċelluli tan-nervituri jikkomunikaw ma'
English: What are the benefits and risks of Memantine Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Memantine Mylan?
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Maltese: NMDA, il-memantina ttejjeb it-trażmissjoni ta' sinjali fil-moħħ u tnaqqas is-sintomi tal-marda ta' Alzheimer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Mylan has been shown to have comparable quality and to be bioequivalent to Ebixa.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) ikkonkluda li, skont ir rekwiżiti tal-UE, intwera li Memantine Mylan għandu kwalità komparabbli u huwa bijoekwivalenti għal Ebixa.
English: Memantine Mylan is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Alzheimer moderata sa gravi, tip ta' dimenzja (disturb fil-moħħ) li b'mod gradwali taffettwa l-memorja, il-kapaċità intellettwali u l-imġiba.
English: To prevent side effects, the dose of Memantine Mylan is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg.
Maltese: Biex jiġu evitati effetti sekondarji, id-doża ta' Memantine Mylan tiżdied b'mod gradwali matul l-ewwel tliet ġimgħat tat-trattament: fl-ewwel ġimgħa d-doża tkun 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fittielet ġimgħa ssir 15 mg.
English: Because Memantine 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 Memantine 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'
English: Why is Memantine Mylan approved?
Maltese: Għaliex ġie approvat Memantine Mylan?
English: This means that Memantine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Maltese: Memantine Mylan huwa ‘mediċina ġenerika' Dan ifisser li Memantine Mylan huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Ebixa.
English: Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Maltese: il-benefiċċji huma akbar mir-riskji identifikati.
English: The Committee recommended that Memantine Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Memantine Mylan ikun approvat għall-użu fl-UE.
English: Because Memantine Mylan is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Maltese: Peress li Memantine Mylan huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Ebixa.
English: Memantine Mylan is a ‘generic medicine'.
Maltese: X'inhu Memantine Mylan u għaxiex jintuża?
English: How has Memantine Mylan been studied?
Maltese: Kif ġie studjat Memantine Mylan?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Memantine Mylan, fosthom il-prekawzjonijiet xierqa li jridu jkunu segwiti mill-professjonisti fil-kura tas-saħħa u l-pazjenti.
English: Grunwaldzka 189 , 60-322 Poznan, Poland
Maltese: Grunwaldzka 189 , 60-322 Poznan, Il-Polonja
English: Lamivudine: AUC ↓ 14%; 32%; 36%
Maltese: AUC ↓ 14%; 32%; 36%
English: (e.g. Kivexa, Ziagen, Triumeq)
Maltese: Kivexa, Ziagen, Triumeq)
English: INFORMATION IN BRAILLE trizivir
Maltese: INFORMAZZJONI BIL-BRAILLE trizivir
English: Date of latest renewal: 2 January 2011
Maltese: Data tal-aħħar tiġdid: 2 ta' Jannar 2011
English: Abacavir: AUC ↔ Cmax ↓35%
Maltese: L-AUC ↔ Is- Cmax ↓35%
English: Percent with <400 copies/mL vRNA
Maltese: <400 copies/mL vRNA
English: ZDV/3TC/ABC ZDV/3TC/EFV ZDV/3TC/ABC/EFV
Maltese: ZDV/3TC/EFV ZDV/3TC/ABC/EFV
English: Virologic failure (HIV RNA >200 copies/ml)
Maltese: Falliment virologiku HIV RNA>200 kopja/ml
English: Rare: anxiety, depression
Maltese: Rari: ansjeta', depressjoni
English: ATC Code: J05AR04.
Maltese: J05AR04
English: Tablet Core: microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate.
Maltese: Qalba tal-Pillola: microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate.
English: MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Maltese: ViiV Healthcare BV
English: • hyperactivity (excessive restlessness and movement)
Maltese: • iperattività (nuqqas ta' sabar u moviment eċċessiv)