FrancophonIA/ELRC3.0 huggingface dataset:
English: One mL of concentrate contains 25 mg of vinflunine (as ditartrate).
Maltese: Kull mL ta' konċentrat fih 25 mg ta' vinflunine (bħala ditartrat).
English: See leaflet
Maltese: Gradi kollha
English: Pain in jaw
Maltese: Kif tingħata l-Javlor
English: The concomittant use of two or more QT/QTc interval prolonging substances is not recommended (see section 4.5).
Maltese: L-użu konkomitani ta' tnejn jew aktar drogi li jdewmu l-intervall QT/QTc mhux rakkomandat (ara sezzjoni 4.5).
English: In order to flush the vein, administration of Javlor solution for infusion should always be followed by at least an equal volume of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion.
Maltese: Sabiex tifflaxxja l-vina, l-għoti ta' Javlor dilwit, għandha dejjem tiġi segwita mill-inqas b'volum ugwali ta' klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-infużjoni jew ta' glukosju 50 mg/mL
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with either cisplatin, carboplatin, capecitabine or gemcitabine.
Maltese: L-ebda interazzjoni farmakokinetika ma ġiet osservata f'pazjenti meta l-vinflunine ingħaqad kemm ma' ċisplatin, karboplatin, kapeċitabin, jew ġemċitabin.
English: - Delay until recovery (ANC ≥ 1,000/mm3 and platelets ≥ 100,000/mm3) and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Maltese: ≥ 100,000/mm3) u aġġusta d-doża jekk hemm bżonn (ara lista 2)
English: The full EPAR for Fertavid 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: EPAR summary for the public follitropin beta
Maltese: Sommarju tal-EPAR għall-pubbliku follitropina beta
English: • women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
Maltese: • nisa li għaddejjin minn trattament ta' fertilità (tekniki ta' riproduzzjoni assistita, bħall fertilizzazzjoni in vitro).
English: The follitropin beta in Fertavid is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Maltese: Il-follitropina beta f'Fertavid hija prodotta permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': hija magħmula minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi l-FSH uman.
English: The active substance in Fertavid, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Maltese: Is-sustanza attiva f'Fertavid, il-follitropina beta, hija kopja tal-ormon naturali li jistimula l-follikola li tistimula l-ormoni (FSH).
English: In 4% of the women treated with Fertavid in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported.
Maltese: F'4% tannisa trattati b'Fertavid fi studji kliniċi, ġew rappurtati sinjali u sintomi relatati mas-sindromu ta' iperstimulazzjoni tal-ovarji (eż. tħossok ma tiflaħx, żieda fil-piż u dijarrea).
English: This is a summary of the European public assessment report (EPAR) for Fertavid.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Fertavid.
English: Fertavid must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Maltese: Fertavid ma għandux jintuża f'pazjenti b'tumuri fl-ovarji, fissider, fil-ġuf, fit-testikoli, fil-glandola pitwitarja jew fl-ipotalama.
English: Fertavid is a solution for injection that contains the active substance follitropin beta.
Maltese: Fertavid hu soluzzjoni għall-injezzjoni li fiha s-sustanza attiva follitropina beta.
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation);
Maltese: • nisa li huma anovulatorji (ma jipproduċux ovuli) u ma jirrispondux għat-trattament ta' klomifen ċitrat (mediċina oħra li tistimula l-ovulazzjoni);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fertavid on 19 March 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fertavid fid-19 ta' Marzu 2009.
English: Fertavid was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Maltese: Fertavid ġie studjat f'172 mara anavolutorja, bil-kejl ta' kemm ċikli ta' trattament kien meħtieġa għal dawn in-nisa sabiex jovulaw.
English: Fertavid's use in women undergoing fertility treatment has been studied in 981 patients.
Maltese: L-użu ta' Fertavid fin-nisa li jgħaddu minn trattament ta' fertilità ġie studjat f'981 pazjent.
English: How has Fertavid been studied?
Maltese: Kif ġie studjat Fertavid?
English: What is Fertavid?
Maltese: X'inhu Fertavid?
English: Treatment with Fertavid should be carried out by a doctor who has experience in the treatment of fertility problems.
Maltese: It-trattament b'Fertavid għandu jsir minn tabib li għandu esperjenza fit-trattament ta' problemi ta' fertilità.
English: This medicine is the same as Puregon, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Puregon, li hija diġà awtorizzata fl-Unjoni Europea (UE).
English: Why has Fertavid been approved?
Maltese: Għaliex ġie approvat Fertavid?
English: Fertavid was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Maltese: Fertavid kien effettiv bħala FSH urinarja bħala trattament ta' fertilità fil-produzzjoni ta' ovoluzzjoni u fil-produzzjoni tal-isperma.
English: Fertavid can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Maltese: Fertavid jista' jintuża wkoll sabiex jistimula l-produzzjoni tal-isperma fl-irġiel li għandhom lipogonadotrofija ipogonadiżmu (marda rari ta' defiċjenza ormonali).
English: In the body, FSH regulates reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Maltese: L-FSH jirregola l-funzjoni riproduttiva fil-ġisem: fin-nisa, jistimula lproduzzjoni tal-ovuli u fl-irġiel jistimula l-produzzjoni tal-isperma mit-testikoli.
English: Previously, the FSH used as a medicine was extracted from urine.
Maltese: Preċedentement, l-FSH użat bħala mediċina kien estratt mill-urina.
English: What is the risk associated with Fertavid?
Maltese: Għal xiex jintuża Fertavid?
English: Fertavid can only be obtained with a prescription.
Maltese: Fertavid kien effettiv daqs il-mediċini ta' tqabbil fl-istudji kollha.
English: Fertavid is used to treat infertility in women in the following situations:
Maltese: Fertavid huwa użat għat-trattament ta' nisa li mhumiex fertili fis-sitwazzjonijiet li ġejjin:
English: Fertavid is administered to stimulate the ovaries to produce more than one egg at a time.
Maltese: Fertavid huwa amministrat sabiex jistimula l-ovarji sabiex jiġu prodotti aktar minn bajda waħda f'ħin wieħed.
English: Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Maltese: Is-sindromu ta' iperstimulazzjoni tal-ovarji jseħħ meta l-ovarji jirrispondu aktar milli suppost għat-trattament.
English: The company that makes Puregon has agreed that its scientific data can be used for Fertavid.
Maltese: Il-kumpanija li tipproduċi Puregon qablet li l-informazzjoni xjentifika tagħha tista' tintuża għal Fertavid.
English: The most common side effects with Fertavid are a reaction and pain at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Fertavid huma reazzjoni u wġiegħ fil-post tal-injezzjoni.
English: Other information about Fertavid
Maltese: Kif jintuża Fertavid?
English: Fertavid should only be administered by people who have been trained by the doctor and have access to expert advice.
Maltese: Fertavid għandu jiġi amministrat biss minn persuni li ġew imħarrġa mit-tabib u li għandhom aċċess għal pariri esperti.
English: In men, Fertavid was studied to see its effect on sperm production in 49 patients.
Maltese: Flirġiel, Fertavid ġie studjat sabiex jiġi ċċekkjat l-effett fuq il-produzzjoni tal-isperma f'49 pazjent.
English: • Oral contraception
Maltese: • Kontraċezzjoni orali
English: [x] is a medicinal product o to prevent pregnancy (contraceptive “pill”).
Maltese: [X] hu prodott mediċinali o biex jipprevjeni t-tqala (“pillola” kontraċettiva).
English: The decision to prescribe [x] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [x] compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Maltese: Id-deċiżjoni li tingħata riċetta għal [x] għandha tikkunsidra l-fatturi tar-riskji kurrenti tal-mara individwali, speċjalment dawk għal tromboemboliżmu fil-vini (VTE - venous thromboembolism), u kif ir-riskju ta' VTE b'[x] jipparaguna ma' kontraċettivi ormonali kkombinati (CHCs - combined hormonal contraceptives) oħrajn (ara sezzjonijiet 4.3 u 4.4).
English: • Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Maltese: • Trattament ta' akne moderata wara li terapiji topiċi adattati jew trattament b'antibijotiċi orali ma jkunux irnexxew f'nisa li jagħżlu li jużaw kontraċettiv orali.
English: Annex III Amendments to relevant sections of the Product Information
Maltese: Anness III Emendi għas-sezzjonijiet rilevanti tal-Informazzjoni tal-Prodott
English: Section 4.2 Posology and method of administration In relation to the acne indication the posology should be revised with the addition of the following statement:
Maltese: Sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata Fir-rigward tal-indikazzjoni tal-akne, il-pożoloġija għandha tiġi riveduta biż-żieda tad-dikjarazzjoni li ġejja:
English: Women should be assessed 3-6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Maltese: In-nisa għandhom jiġu evalwati 3-6 xhur wara lbidu tat-trattament u perjodikament wara dan biex tiġi riveduta l-ħtieġa għallkontinwazzjoni tat-trattament.
English: Section 4.1 Therapeutic indications The acne indication should be revised to read as follows:
Maltese: Sezzjoni 4.1 Indikazzjonijiet terapewtiċi
English: Amendments to relevant sections of the Product Information
Maltese: Emendi għas-sezzjonijiet rilevanti tal-Informazzjoni tal-Prodott
English: Apparent improvement of acne usually takes at least three months and further improvement has been reported after six months of treatment.
Maltese: Titjib evidenti tal-akne normalment jieħu mill-inqas tliet xhur u titjib addizzjonali ġie rrappurtat wara sitt xhur ta' trattament.
English: o For treatment of women with moderate acne who agree to receive a contraceptive pill after failure of suitable local or oral antibiotic treatments.
Maltese: o Għat-trattament ta' nisa b'akne moderata li jaqblu li jirċievu pillola kontraċettiva wara li trattamenti b'antibijotiċi lokali jew orali xierqa ma jkunux irnexxew.
English: You should discuss with your doctor the need to continue your treatment three to six months after the start and regularly thereafter.
Maltese: Għandek tiddiskuti mat-tabib tiegħek il-ħtieġa li tkompli t-trattament tiegħek tlieta sa sitt xhur wara l-bidu u regolarment wara dan.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Maltese: L-informazzjoni eżistenti tal-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir talkitba, kif xieraq) biex tirrifletti l-kitba li dwarha kien hemm qbil, kif deskritt hawn taħt.
English: A. Summary of Product Characteristics
Maltese: Sommarju tal-Karatteristiċi tal-Prodott
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Maltese: Skond l-Artikolu 33(4) tad-Direttiva tal-Kunsill 2001/82/KE, kif emendata, il-materja ġiet referita lis-CVMP.
English: The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 26 November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution.
Maltese: L-Olanda, Stat Membru ta' referenza fil-proċedura ta' deċentralizzazzjoni, fis-26 ta' Novembru 2007, għarraf lill-EMEA li l-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u l-Proċeduri Deċentralizzati - Veterinarji (is-CMD(v)) naqas milli jilħaq ftehim dwar it-trab ta' Solacyl 100% għassoluzzjoni orali.
English: Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
Maltese: Għoġġiela: 20 mg sodium salicylate għal kull kg piż korporali darbtejn kuljum, għal 1 sa 3 ijiem.
English: Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
Maltese: Majjali: 35 mg sodium salicylate għal kull kg piż korporali, għal bejn 3 u 5 ijiem.
English: A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007.
Maltese: Is-CVMP adotta Lista ta' Mistoqsijiet u din intbagħtet lill-applikant fit-12 ta' Diċembru 2007.
English: Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%.
Maltese: Ġie ppruvat li t-trab ta' Solacyl 100% għas-soluzzjoni orali kien essenzjalment simili għall-prodott ta' referenza, Natrium salicylaat 100%.
English: CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame.
Maltese: Is-CVMP beda l-proċedura fil-11 ta' Diċembru 2007 u qabel fuq perjodu ta' 37 jum.
English: Solacyl powder for oral solution powder
Maltese: Solacyl 100% trab għal soluzzjoni orali trab
English: CVMP noted that Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands) and that the concerns raised by Ireland could only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Maltese: Is-CVMP innota li t-trab ta' Solacyl 100% għas-soluzzjoni orali huwa ġeneriku ta' Natrium salicylaat (awtorizzat fl-Olanda) u li t-tħassib imqajjem mill-Irlanda jista' jiġi indirizzat biss fil-qafas ta' din ilproċedura, fil-każ li jkun hemm xi differenzi bejn iż-żewġ prodotti li tkun tista' tiġġustifika lkonklużjonjiet differenti għas-sigurtà u l-effikaċja.
English: Administration: orally in drinking water or milk(replacer).
Maltese: Amministrazzjoni: oralment fl-ilma taxxorb jew ħalib(sostitut).
English: Administration: orally in drinking water.
Maltese: Amministrazzjoni: oralment fl-ilma taxxorb.
English: Product invented name
Maltese: Isem inventat tal-prodott
English: Alternatively Solacyl can also be administered with the drinking water as pulse medication.
Maltese: Inkella Solacyl jista' jingħata wkoll ma' lilma tax-xorb bħala mediċina għal perjodu qasir.
English: In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Maltese: Bi tweġiba għall-mistoqsija numru 1, l-applikant ipprovda kopja tad-dossier oriġinali kif ippreżentat b'appoġġ għall-applikazzjoni tal-proċedura ta' proċedura deċentralizzata, u d-dejta supplimentari ppreżentata waqt il-proċedura deċentralizzata bi tweġiba għall-valutazzjoni tal-fażi I u tal-fażi
English: Consequently, the same conclusions on efficacy and safety apply to both products.
Maltese: Konsegwentament, japplikaw l-istess konklużjonijiet għalleffikaċja u s-sigurtà għaż-żewġ prodotti.
English: Calves and pigs oral
Maltese: Għoġġiela orali
English: It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Maltese: Huwa rakkomandat li t-trab għas-soluzzjoni Solacyl 100% għall-għoġġiela u l-majjali isegwi r-riżultat tar-Riferiment tal-Komunità skond l-Artikolu għal trabijiet orali li jinħallu fl-ilma li fihom is-sodium salicylate.
English: The application dossier and any data added to it up to Day 60 of the referral procedure in CMD(v) to be provided to all CVMP Members and the EMEA.
Maltese: Jum tal-proċedura tar-riferiment fis-CMD(v) jiġi pprovdut lill-Membri kollha tas-CVMP u lill-EMEA.
English: Ireland considers that, due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Maltese: L-Irlanda tqis li, minħabba n-nuqqas ta' dokumentazzjoni dwar l-effikaċja wieħed ma jistax jassumi li l-prodott huwa effikaċi u li dan jippreħenta riskju serju potenzjali għas-saħħa ta' l-annimali.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Maltese: ANNESS I L-ISEM, L-GĦAMLA FARMAĊEWTIKA, IL-QAWWA, L-ISPEĊI TA' ANNIMAL, MNEJN JINGĦATA U D-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: On the basis of the grounds for referral CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Maltese: Jindika u jissostanzja fejn meħtieġ, id-differenzi kollha bejn it-trab ta' Solacyl 100% u l-prodott ta' referenza li jistgħu jiġġustifikaw il-konklużjonijiet differenti fuq l-effikaċja taż-żewġ prodotti.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
Maltese: ANNESS III SOMMARJU TAL-KARATTERISTIĊI
English: Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B.
Maltese: Ħafif: Child-Pugh Klassi A; Moderat: Child-Pugh Klassi B.
English: MedDRA System organ class
Maltese: MedDRA Sistema tal-klassi tal-organi
English: Renal impairment(1)
Maltese: Indeboliment renali(1)
English: PC: {number} SN: {number} NN:
Maltese: {numru} SN:
English: Insomnia* Confusional state*
Maltese: Insonja* Stat konfużjonali
English: Date of first authorisation: 20 December 2012 Date of latest renewal: 18 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 Diċembru 2012 Data tal-aħħar tiġdid: 18 ta' Settembru 2017
English: Hepatic impairment(2)
Maltese: Indeboliment talfwied(2)
English: Κύπρος Ελλάδα
Maltese: Κύπρος
English: Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Maltese: Folji Alu-Alu f'kartuni ta' 10, 20, 30, 50, 60, 90, 100 jew 200 pillola.
English: Study 074
Maltese: Studju 074
English: - The active substance is mirabegron.
Maltese: - Is-sustanza attiva hi mirabegron.
English: Study 046
Maltese: Studju 046
English: Mild: GFR 60 to 89 mL/min/1.73 m2; moderate: GFR 30 to 59 mL/min/1.73 m2; severe: GFR 15 to 29 mL/min/1.73 m2.
Maltese: Ħafif: GFR 60 sa 89 mL/min/1.73 m2; moderat: GFR 30 sa 59 mL/min/1.73 m2; sever: GFR
English: Study 047
Maltese: Studju 047
English: Mirabegron is a substrate for cytochrome P450 (CYP) 3A4, CYP2D6, butyrylcholinesterase, uridine diphospho-glucuronosyltransferases (UGT), the efflux transporter P-glycoprotein (P-gp) and the influx organic cation transporters (OCT) OCT1, OCT2, and OCT3.
Maltese: Mirabegron huwa substrat għal cytochrome P450 (CYP) 3A4, CYP2D6, butyrylcholinesterase, uridine diphospho-glucuronosyltransferases (UGT), it-trasportatur effluss P-glikoproteina (P-gp) u t trasportaturi influss ta' katjoni organiċi (OCT) OCT1, OCT2, u OCT3.
English: Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only).
Maltese: Qalba tal-pillola: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Kisi b'rita: Hypromellose, macrogol, iron oxide isfar (E172), iron oxide aħmar (E172) (il-pillola ta' 25 mg biss).
English: Mirabegron is a potent and selective beta 3-adrenoceptor agonist.
Maltese: Mirabegron huwa beta 3-adrenoceptor agonist qawwi u selettiv.
English: {DD/MM/YYYY}
Maltese: {XX/SSSS}
English: Iron oxide yellow (E172) Iron oxide red (E172)
Maltese: Iron oxide aħmar (E172)
English: Mirabegron increased Cmax and AUC by 29% and 27%, respectively, of the P-gp substrate digoxin in healthy volunteers.
Maltese: Mirabegron żied Cmax u AUC b'29% u 27%, rispettivament, ta' substrat P-gp digoxin f'voluntiera b'saħħithom.
English: Effect on intraocular pressure (IOP)
Maltese: Effett fuq il-pressjoni intraokulari (IOP)
English: Summary of the safety profile
Maltese: Sommarju tal-profil sigur
English: Mirabegron did not induce CYP1A2 or CYP3A.
Maltese: Mirabegron ma induċiex CYP1A2 jew CYP3A.
English: Dyspepsia Gastritis
Maltese: Dispepsija Gastrite
English: Placebo Mirabegron 50 mg
Maltese: Plaċebo Mirabegron 50 mg
English: EU/1/12/809/008 10 prolonged-release tablets EU/1/12/809/009 20 prolonged-release tablets EU/1/12/809/010 30 prolonged-release tablets EU/1/12/809/011 60 prolonged-release tablets EU/1/12/809/012 90 prolonged-release tablets EU/1/12/809/013 200 prolonged-release tablets EU/1/12/809/017 50 prolonged-release tablets EU/1/12/809/018 100 prolonged-release tablets
Maltese: EU/1/12/809/008 10 pillola b'rilaxx prolungat EU/1/12/809/009 20 pillola b'rilaxx prolungat EU/1/12/809/010 30 pillola b'rilaxx prolungat EU/1/12/809/011 60 pillola b'rilaxx prolungat EU/1/12/809/012 90 pillola b'rilaxx prolungat EU/1/12/809/013 200 pillola b'rilaxx prolungat EU/1/12/809/017 50 pillola b'rilaxx prolungat EU/1/12/809/018 100 pillola b'rilaxx prolungat
English: The MAH has cumulatively reviewed the cases of confusional state using the HLGT Deliria (including confusion).
Maltese: L-MAH għamel reviżjoni kumulattiva tal-każijiet ta' stat konfużjonali bl-użu ta' HLGT Deliria (inkluż konfużjoni).
English: Strong CYP3A inhibitors see section 4.5
Maltese: Inibituri qawwija ta' CYP3A, ara s-sezzjoni 4.5
English: Tachycardia Palpitation Atrial fibrillation
Maltese: Disturbi fil-qalb Takikardija Palpitazzjoni Fibrillazzjoni tal-atriju
English: EU/1/12/809/001 10 prolonged-release tablets EU/1/12/809/002 20 prolonged-release tablets EU/1/12/809/003 30 prolonged-release tablets EU/1/12/809/004 60 prolonged-release tablets EU/1/12/809/005 90 prolonged-release tablets EU/1/12/809/006 200 prolonged-release tablets EU/1/12/809/015 50 prolonged-release tablets EU/1/12/809/016 100 prolonged-release tablets
Maltese: EU/1/12/809/001 10 pillola b'rilaxx prolungat EU/1/12/809/002 20 pillola b'rilaxx prolungat EU/1/12/809/003 30 pillola b'rilaxx prolungat EU/1/12/809/004 60 pillola b'rilaxx prolungat EU/1/12/809/005 90 pillola b'rilaxx prolungat EU/1/12/809/006 200 pillola b'rilaxx prolungat EU/1/12/809/015 50 pillola b'rilaxx prolungat EU/1/12/809/016 100 pillola b'rilaxx prolungat
English: Betmiga contains the active substance mirabegron.
Maltese: Betmiga fih is-sustanza attiva mirabegron.
English: The volume of distribution at steady state (Vss) is approximately 1670 L. Mirabegron is bound (approximately 71%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
Maltese: Il-volum ta' distribuzzjoni fi stat stabbli (Vss) - huwa madwar 1,670 L. Mirabegron jingħaqad (madwar 71%) mal-proteini tal-plażma umani, u juri affinità moderata ma' albumin u glikoproteina alpha-1 acid.
English: Astellas Pharma Tlf: +47 66 76 46 00
Maltese: Tlf: +47 66 76 46 00
English: Macrogol 8,000 and 2,000,000 Hydroxypropylcellulose Butylhydroxytoluene Magnesium stearate
Maltese: Hydroxypropylcellulose Butylhydroxytoluene Magnesium stearate