FrancophonIA/ELRC3.0 huggingface dataset:
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Maltese: Għandha tingħata attenzjoni meta jintuża rivastigmine f'pazjenti bis-sindrome tas-sinus marid jew b'difetti tal-konduttività fil-qalb (imblukkar sinoatrijali, imblukkar atrijuventrikulari) (ara sezzjoni
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Komuni (jaffettwa bejn pazjent wieħed u 10 pazjenti minn kull 100)
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Maltese: Il-kapsuli u s-soluzzjoni orali jistgħu jintużaw wkoll għall-kura ta' dimenzja f'pazjenti adulti bil-marda ta' Parkinson.
English: Similarly a larger effect was observed in Parkinson's disease patients with visual hallucinations (see section 5.1).
Maltese: B'mod simili, effett akbar deher f'pazjenti bilmarda ta' Parkinson li kellhom alluċinazzjonijiet viżivi (ara sezzjoni 5.1).
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Maltese: Billi jimblokka dawn l-enzimi, Rivastigmine Actavis jippermetti l-livelli ta' acetylcholine jiżdiedu fil-moħħ, li jgħin biex jitnaqqsu ssintomi tal-marda ta' Alzheimer u d-dimenzja marbuta mal-marda ta' Parkinson.
English: Mean change at 24 weeks 2.5 ± 8.4 ± SD
Maltese: Tħossok ma tiflaħx
English: Tel: +48 22 345 93 00
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 22 345 93 00
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: • Taqa' b'mod aċċidentali
English: 10 (2 x 5) prefilled pens (multipack)
Maltese: 10 (2 x 5) pinen mimlijin għal-lest (pakketti multipli)
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem
English: 1 pre-filled pen + 7 NovoTwist needles
Maltese: Pinna 1 mimlija għal-lest + 7 labar NovoTwist
English: 1 pre-filled pen + 7 NovoFine needles
Maltese: Pinna 1 mimlija għal-lest + 7 labar NovoFine
English: 5 pre-filled pens
Maltese: 5 pinen mimlijin għal-lest
English: Pack size
Maltese: (ivvintat)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 August 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 ta' Awwissu 2018
English: It contains the active substance mepivacaine.
Maltese: Dan fih is-sustanza attiva mepivacaine.
English: In children, the recommended dose is 0.75 mg/kg.
Maltese: Fit-tfal, id-doża rrakkomandata hija 0.75 mg/kg.
English: EMA/533239/2018 Rev. 1 EMEA/H/A-30/1455
Maltese: EMA/533239/2018 Rev.
English: Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).
Maltese: Sezzjonijiet armonizzati oħra tal-SmPC jinkludu s-sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.5 (interazzjonijiet), 4.6 (fertilità, tqala u treddigħ), 4.7 (effetti fuq il-ħila biex issuq u tħaddem magni), u 4.8 (effetti sekondarji).
English: In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg.
Maltese: Fl-adulti, iddoża rrakkomandata massima hija 4.4 mg għal kull kg tal-piż tal-ġisem, sa doża totali massima ta' 300 mg.
English: Scandonest is given by injection.
Maltese: Scandonest jingħata permezz ta' injezzjoni.
English: What is Scandonest?
Maltese: X'inhu Scandonest?
English: On 25 August 2017, Septodont, the company that markets Scandonest, referred the matter to EMA in order to harmonise the marketing authorisations for Scandonest in the EU.
Maltese: Fil-25 ta' Awwissu 2017, Septodont, il-kumpanija li tqiegħed Scandonest fis-suq, irreferiet il-kwistjoni lill-EMA sabiex jiġu armonizzati l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Scandonest fl-UE.
English: The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Scandonest inbeda fuq talba tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Septodont, skont l-Artikolu 30 tad-Direttiva 2001/83/KE.
English: Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures.
Maltese: Scandonest huwa anestetiku lokali, mediċina li tintuża biex timblokka s-sensazzjoni u l-uġigħ f'parti tal-ġisem waqt proċeduri mediċi.
English: Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.
Maltese: Scandonest jiġi wkoll fl-UE taħt l-ismijiet kummerċjali Biocaine u Scandicaine.
English: After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised.
Maltese: Wara li kkunsidrat id-data disponibbli dwar l-użu ta' Scandonest, l-Aġenzija kkonkludiet li l-SmPC għandu jiġi armonizzat.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised EMA/533239/2018
Maltese: EMA/533239/2018
English: Scandonest is now authorised for use as local anaesthetic in dental surgery in adults, adolescents and children above 4 years of age (weighing around 20 kg).
Maltese: Scandonest issa huwa awtorizzat għall-użu bħala anestetiku lokali f'kirurġija tas-snien fl-adulti, fladolexxenti u fit-tfal ta' 'l fuq mill-età ta' 4 snin (li jiżnu madwar 20 kg).
English: On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Maltese: Fil-31 ta' Mejju 2018, l-Aġenzija Ewropea għall-Mediċini (EMA) temmet rieżami ta' Scandonest u ismijiet assoċjati u rrakkomandat tibdil fl-informazzjoni tal-preskrizzjoni sabiex jiġi armonizzat il-mod kif tintuża l-mediċina fl-UE.
English: Scandonest should no longer be used as local anaesthetic during chiropody procedures (treatment of corns, verrucae, etc.), because the data presented by the company were considered not sufficient to support this use.
Maltese: Scandonest m'għandux jibqa' jintuża bħala anestetiku lokali waqt proċeduri ta' kiropodija (kura ta' kallijiet żgħar, verruki, eċċ.), minħabba li d-data ppreżentata mill-kumpanija tqieset mhux suffiċjenti sabiex tappoġġja dan l-użu.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Maltese: Ir-rieżami sar mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA, responsabbli għall-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem.
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information [summary of product characteristics (SmPC), labelling and package leaflet] in the countries where the medicine is marketed.
Maltese: Dan wassal għal inkonsistenza flIstati Membri fil-mod ta' kif tiġi prodotta u użata l-mediċina, kif jidher fid-differenzi fl-informazzjoni talpreskrizzjoni [is-sommarju tal-karatteristiċi tal-prodott (SmPC), it-tikkettar u l-fuljett ta' tagħrif] filpajjiżi fejn il-mediċina titqiegħed fis-suq.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above.
Maltese: Wara rieżami tad-data disponibbli, numru ta' kontraindikazzjonijiet oħra li kienu validi biss f'xi pajjiżi tqiesu li ma ġewx appoġġjati minn data suffiċjenti, jew li kienu żejda u diġà inklużi fil-lista attwali ta' hawn fuq.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.
Maltese: Fejn ġie ġġustifikat mid-data, xi wħud mill-kontraindikazzjonijiet preċedenti ġew inklużi fissezzjoni 4.4 ‘Twissijiet speċjali u prekawzjonijiet għall-użu'.
English: In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.
Maltese: Barra minn hekk, il-Modulu 3 tad-dossier tal-mediċina (li jiddeskrivi kif tiġi prodotta l-mediċina u kif tiġi kkontrollata l-kwalità tagħha) ukoll ġie armonizzat.
English: Information for doctors and patients to be aligned across EU
Maltese: Informazzjoni għat-tobba u għall-pazjenti għandha tiġi allinjata madwar l-UE
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 2 August 2018.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti mal-UE kollha għall-implimentazzjoni ta' dawn il-bidliet fit-2 ta' Awwissu 2018.
English: Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine.
Maltese: Scandonest m'għandux jintuża f'pazjenti li huma allerġiċi għas-sustanza attiva mepivacaine jew għal xi waħda mill-ingredjenti l-oħra tal-mediċina.
English: In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.
Maltese: Barra minn hekk, dan m'għandux jintuża fi tfal taħt l-età ta' 4 snin, f'pazjenti bi problemi severi li jaffettwaw l-attività elettrika tal-qalb li ma jissolvewx b'pacemaker, u f'pazjenti epilettiċi li l-marda tagħhom m'hijiex ikkontrollata b'mod adegwat.
English: Content
Maltese: Pakkett
English: EMA/76094/2014 EMEA/H/C/002284
Maltese: EMEA/H/C/002284
English: The full EPAR for NovoThirteen 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: This is a summary of the European public assessment report (EPAR) for NovoThirteen.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal NovoThirteen.
English: NovoThirteen catridecacog
Maltese: Sommarju tal-EPAR għall-pubbliku catridecacog
English: Other information about NovoThirteen
Maltese: Informazzjoni oħra dwar NovoThirteen
English: The active substance in NovoThirteen, catridecacog, is structurally the same as the human factor XIII A-subunit.
Maltese: Is-sustanza attiva f'NovoThirteen, catridecacog, hija strutturalment l-istess bħas-subunità A tal-fattur XIII uman.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoThirteen on 3 September 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal NovoThirteen valida fl-Unjoni Ewropea kollha fit-3 ta' Settembru 2012.
English: The most common side effects with NovoThirteen (seen in between 1 and 10 patients in 100) are headache, leucopenia (low white blood cell counts), aggravated neutropenia (low levels of neutrophils, a type of white blood cell), pain in the extremities, injection site pain, and the presence in the blood of antibodies that attach to factor XIII and of small protein fragments called ‘fibrin D-dimer'.
Maltese: L-aktar effetti sekondarji komuni b'NovoThirteen (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma wġigħ ta' ras, lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), newtropenija aggravata (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), uġigħ fl-estremitajiet, uġigħ fis-sit tal-injezzjoni, u l-preżenza fid-demm ta' antikorpi li jeħlu mal-fattur XIII u ta' frammenti żgħar ta' proteini msejħa ‘fibrin D-dimer'.
English: What is NovoThirteen?
Maltese: X'inhu NovoThirteen?
English: NovoThirteen is a medicine that contains the active substance catridecacog.
Maltese: NovoThirteen hija mediċina li fiha s-sustanza attiva catridecacog.
English: The recommended dose is 35 international units (IU) per kilogram body weight once per month.
Maltese: Id-doża rakkomandata hija 35 unità internazzjonali (UI) għal kull kilogramm ta' piż tal-ġisem darba fixxahar.
English: NovoThirteen was investigated in a main study involving 41 adults and children above 6 years of age with congenital factor XIII A-subunit deficiency who had been treated in the past with medicines containing factor XIII.
Maltese: NovoThirteen ġie investigat fi studju prinċipali li kien jinvolvi 41 adulti u tfal minn 6 snin 'il fuq b'defiċjenza konġenitali ta' subunità A tal-fattur XIII li fil-passat kienu ġew ikkurati b'mediċini li kien fihom il-fattur XIII.
English: The factor XIII A-subunit in NovoThirteen is made by a method known as ‘recombinant DNA technology': it is produced by yeast cells that have received the gene (DNA) which makes the cells able to produce it.
Maltese: Is-subunità A tal-fattur XIII f'NovoThirteen hija magħmula b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': hija tiġi prodotta minn ċelloli tal-ħmira li jkunu rċevew il-ġene (DNA) li jagħmel iċ-ċelloli kapaċi li jipproduċuh.
English: A risk management plan has been developed to ensure that NovoThirteen is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li NovoThirteen jintuża bl-aktar mod sigur possibbli.
English: Why has NovoThirteen been approved?
Maltese: Għaliex ġie approvat NovoThirteen?
English: NovoThirteen is used for the long-term prevention of bleeding in patients with a condition called ‘congenital factor XIII A-subunit deficiency'.
Maltese: NovoThirteen jintuża għall-prevenzjoni fit-tul ta' tnixxija tad-demm f'pazjenti bil-kondizzjoni msejħa ‘defiċjenza konġenitali ta' subunità A tal-fattur XIII'.
English: This includes information on storage procedures, since incorrect storage after reconstitution can cause increased levels of activated NovoThirteen, thereby increasing the risk of thrombosis (formation of blood clots in the blood vessels), and information on administration procedures, since the factor XIII concentration in NovoThirteen is different from other factor XIIIcontaining medicines.
Maltese: Dan jinkludi informazzjoni dwar il-proċeduri ta' ħażna, billi ħażna ħażina wara r-rikostituzzjoni tista' tikkawża livelli ogħla ta' NovoThirteen attivat u b'hekk jiżdied ir-riskju ta' trombożi (formazzjoni ta' emboli fil-vini u l-arterji), u l-informazzjoni fuq il-proċeduri talgħoti, billi l-konċentrazzjoni ta' fattur XIII f'NovoThirteen hija differenti minn mediċini oħra li fihom ilfattur XIII.
English: This is an inherited blood clotting disorder characterised by bleeding episodes.
Maltese: Dan huwa disturb ereditarju tal-koagulazzjoni taddemm ikkaratterizzat minn episodji ta' tnixxija tad-demm.
English: Factor XIII is a protein involved in the blood clotting process.
Maltese: Il-fattur XIII hija proteina involuta fil-proċess ta' koagulazzjoni tad-demm.
English: A specific component of factor XIII called the A-subunit is involved in stabilising blood clots and increasing the strength of the clot.
Maltese: Komponent speċifiku talfattur XIII imsejjaħ is-subunità A huwa involut fl-istabbilizzazzjoni tal-emboli u ż-żieda fis-saħħa talembolu.
English: The rate of bleeding episodes in patients receiving NovoThirteen preventatively was lower than the rate seen in the earlier data from patients treated on demand with another medicine containing factor XIII.
Maltese: Ir-rata tal-episodji ta' tnixxija tad-demm f'pazjenti li rċevew NovoThirteen għall-prevenzjoni kienet aktar baxxa mir-rata li dehret fid-dejta preċedenti minn pazjenti kkurati b'mediċina oħra li kien fiha lfattur XIII.
English: It is available as a powder and solvent to be made up into a solution for injection.
Maltese: Jiġi bħala trab u solvent biex tiġi prodotta soluzzjoni għall-injezzjoni.
English: This compared with around 2.9 episodes per year per patient treated on demand with another medicine containing factor XIII.
Maltese: Dan kien jikkumpara ma' bejn wieħed u ieħor 2.9 episodji fis-sena għal kull pazjent ikkurat meta meħtieġ b'mediċina oħra li kien fiha l-fattur XIII.
English: The CHMP concluded that the main study provided satisfactory results in terms of effectiveness, since no severe or life-threatening bleedings took place during treatment with NovoThirteen.
Maltese: Barra minn hekk, ma dehrux effetti sekondarji maġġuri fl-użu fit-tul ta' NovoThirteen.
English: The safety and effectiveness of NovoThirteen in children below 6 years of age was supported by preliminary data from an ongoing long-term study during which the patients were given NovoThirteen to prevent bleeding episodes.
Maltese: Is-sigurtà u l-effikaċja ta' NovoThirteen fi tfal taħt is-6 snin kienu bbekkjati minn data preliminari minn studju attwali fit-tul li matulu l-pazjenti ngħataw NovoThirteen biex jipprevejni episodji ta' tnixxija ta' demm.
English: How has NovoThirteen been studied?
Maltese: Kif ġie studjat NovoThirteen?
English: What is the risk associated with NovoThirteen?
Maltese: X'inhu r-riskju assoċjat ma' NovoThirteen?
English: On average, there were approximately 0.15 bleeding episodes requiring factor XIII treatment per year per patient treated preventatively with NovoThirteen.
Maltese: Bħala medja, kien hemm madwar 0.15 episodju ta' tnixxija tad-demm li kienu jeħtieġu kura bil-fattur XIII fis-sena għal kull pazjent ikkurat b'mod preventiv b'NovoThirteen.
English: The patients were given NovoThirteen for one year for preventative use.
Maltese: Il-pazjenti ngħataw NovoThirteen għal sena waħda għal użu preventiv.
English: EMA/483664/2014 EMEA/H/C/001180
Maltese: EMEA/H/C/001180
English: The full EPAR for Vantavo 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: Other information about Vantavo:
Maltese: Informazzjoni oħra dwar Vantavo:
English: Why has Vantavo been approved?
Maltese: Għaliex ġie approvat Vantavo?
English: This document is a summary of the European Public Assessment Report (EPAR) for Vantavo.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vantavo.
English: Vantavo alendronic acid and colecalciferol
Maltese: Vantavo aċidu alendroniku u colecalciferol
English: 1 Previously known as Alendronate Sodium And Colecalciferol, MSD.
Maltese: 1 Preċedentement magħruf bħala Alendronate Sodium And Colecalciferol, MSD.
English: The European Commission granted a marketing authorisation valid throughout the EU for Alendronate Sodium And Colecalciferol, MSD on 16 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Alendronate Sodium And Colecalciferol, MSD fis-16 ta' Ottubru 2009.
English: The name of the medicine was changed to Vantavo on 26 March 2010.
Maltese: L-isem tal-mediċina nbidel għal Vantavo fis-26 ta' Marzu 2010.
English: This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Maltese: Din l-awtorizazzjoni kienet ibbażata fuq lawtorizzazzjoni li ngħatat lil Fosavance fl-2005 (‘kunsens infurmat').
English: In the extension study, similar numbers of patients taking Vantavo 70 mg/2,800 IU and Vantavo 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Vantavo 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Maltese: Flistudju mtawwal, f'numru simili ta' pazjenti kkurati b'Vantavo 70 mg/2,800 IU u b'Vantavo 70 g/5,600 IU ġew osservati livelli baxxi tal-vitamina D (taħt 6%), iżda fil-pazjenti ttrattati b'Vantavo 70 mg/5,600 IU ġew osservati żidiet ogħla fil-livelli tal-vitamina D fuq il-perjodu ta' 24 ġimgħa li kopra l-istudju.
English: The most common side effects with Vantavo include abdominal pain (stomach ache), dyspepsia (heartburn), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
Maltese: L-effetti sekondarji l-aktar komuni b'Vantavo jinkludu uġigħ addominali (uġigħ fl-istonku), dispepsija (qrusa tal-istonku), ulċeri fl-esofagu (fil-gerżuma), disfaġija (diffikultà meta tibla'), distensjoni addominali (żaqq minfuħa) u tlugħ ta' aċidu mill-istonku.
English: It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).
Maltese: [IU] colecalciferol; 70 mg aċidu alendroniku u 5,600 IU colecalciferol).
English: Vantavo contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Maltese: Vantavo fih żewġ sustanzi attivi: l-aċidu alendroniku u l-colecalciferol (vitamina D3).
English: This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Vantavo 70 mg/2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Vantavo 70 mg/5,600 IU).
Maltese: Dan listudju ttawwal għal 24 ġimgħa oħra għal 652 pazjent biex jitqabblu l-effetti bejn it-tkomplija ta' Vantavo 70 mg/2,800 IU waħdu jew biż-żieda ta' 2,800 IU vitamina D3 (li huwa ekwivalenti għall-użu ta' Vantavo 70 mg/5,600 IU).
English: After 15 weeks, fewer patients had low vitamin D levels when they took Vantavo 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Maltese: Wara 15-il ġimgħa, inqas pazjenti kellhom livelli baxxi tal-vitamina D meta ħadu Vantavo 70 mg/2,800 IU (11%) milli meta ħadu l-aċidu alendroniku waħdu (32%).
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Maltese: Il-pazjent għandu jibla' l-pillolla b'tazza ilma mimlija (iżda mhux ilma minerali), mill-anqas 30 minuta qabel kwalunkwe ikel, xorb, jew mediċina oħra (fosthom antiaċidi, supplimenti tal-kalċju u vitamini).
English: What is the risk associated with Vantavo?
Maltese: X'inhu r-riskju assoċjat ma' Vantavo?
English: How has Vantavo been studied?
Maltese: Kif ġie studjat Vantavo?
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Maltese: Minħabba li l-aċidu alendroniku u l-vitamina D3 diġà jintużaw separatament f'mediċini awtorizzati flUE, il-kumpanija ppreżentat dejta li kienet inkisbet fi studji preċedenti u mid-dokumentazzjoni ppubblikata dwar nisa li kienu għaddew mill-menopawża u li kienu qegħdin jieħdu l-aċidu alendroniku u l-vitamina D bħala pilloli separati.
English: Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Maltese: Ilvitamina D3, flimkien ma' forom oħra tal-vitamina D, hija neċessarja għall-assorbiment tal-kalċju u għall-formazzjoni normali tal-għadam.
English: What is Vantavo?
Maltese: X'inhu Vantavo?
English: How does Vantavo work?
Maltese: Għal xiex jintuża Vantavo?
English: The CHMP decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Vantavo huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Vantavo's ability to increase vitamin D levels.
Maltese: Bħala appoġġ għall-kombinazzjoni tal-aċidu alendroniku u l-vitamina D3 fl-istess pillola, il-kumpanija wettqet ukoll studju f'717-il pazjent li kellhom l-osteoporożi, inklużi 682 mara li kienu għaddew millmenopawża, sabiex tintwera l-kapaċità ta' Vantavo biex iżid il-livelli tal-vitamina D. Lill-pazjenti ngħatalhom Vantavo 70 mg/2,800 IU jew l-aċidu alendroniku darba fil-ġimgħa biss.