FrancophonIA/ELRC3.0 huggingface dataset:
English: For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Maltese: Għall-kanċer tal-prostata, billi jkun hemm l-użu fl-istess ħin ta' prednisone jew prednisolone, il-kors irrakkomandat tal-premedikazzjoni hu t-teħid ta' 8 mg dexamethasone oralment, 12-il siegħa, 3 sigħat u siegħa qabel l-infużjoni ta' docetaxel (ara sezzjoni 4.4).
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Maltese: Qtugħ ta' nifs (G3/4: 1%); Sogħla (G3/4: < 1%);
English: Neutropenia (G3/4: 83.2%);
Maltese: Newtropenija (G3/4: 32%);
English: Docefrez 20 mg powder for concentrate for solution for infusion
Maltese: Docefrez 20 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Package size blister (PVC/alu) 336 (4 packs of 84) hard capsules blister (PVC/alu) 84 hard capsules
Maltese: 336 (4 pakketti ta' 84) kapsula iebsa
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem (inventat) Qawwa Għamla farmaċewtika
English: These should be submitted to the National Competent Authorities:
Maltese: Kompetenti rilevanti:
English: A visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products-containing oral retinoids acitretin, alitretinoin and isotretinoin.
Maltese: Tfakkira viżiva fuq l-imballaġġ estern li twissi lill-pazjenti dwar ilħsara lit-tarbija fil-ġuf u l-ħtieġa ta' kontraċezzjoni effettiva meta jintuża l-prodott mediċinali għandha tiġi implimentata fil-prodotti mediċinali kollha li fihom ir-retinojdi orali acitretin, alitretinoin u isotretinoin.
English: In order to assess the effectiveness of the updated risk minimisation measures in women of childbearing potential resulting from this referral procedure, MAH(s) of oral retinoids acitretin, alitretinoin and isotretinoin should conduct and submit the results of a drug utilisation study (DUS).
Maltese: Sabiex jivvalutaw l-effikaċja tal-miżuri aġġornati għallminimizzazzjoni tar-riskju f'nisa li jistgħu joħorġu tqal li jirriżulta minn din il-proċedura ta' referenza, l-MAH(s) tar-retinojdi orali acitretin, alitretinoin u isotretinoin għandhom iwettqu u jissottomettu r-riżultati ta' studju dwar l-użu magħmul mill-mediċina (DUS).
English: The marketing authorisation holder(s) for oral retinoids acitretin, alitretinoin and isotretinoin shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Maltese: Dawn għandhom jiġu ppreżentati lill-Awtoritajiet Nazzjonali Kompetenti:
English: The MAHs of oral retinoids containing acitretin, alitretinoin or isotretinoin shall develop and submit educational materials according to the agreed key elements.
Maltese: L-MAHs ta' retinojdi orali li li fihom l-acitretin, l-alitretinoin jew l isotretinoin għandhom jiżviluppaw u jippreżentaw materjali edukattivi skont l-elementi ewlenin maqbula.
English: These materials should ensure that prescribers are informed and the patients understand and acknowledge the risks associated with oral retinoids acitretin, alitretinoin and isotretinoin in-utero exposure.
Maltese: Dawn il-materjali għandhom jiżguraw li l-preskriventi jiġu informati u l-pazjenti jifhmu u jirrikonoxxu r-riskji assoċjati mal-esponiment fl-utru għar-retinojdi orali acitretin, alitretinoin u isotretinoin.
English: The details of the visual reminder should be agreed at national level further to a user test taking into account input from local patient representatives.
Maltese: Għandu jkun hemm qbil dwar id-dettalji tat-tfakkira viżiva fil-livell nazzjonali wara test mill-utent filwaqt li jitqies l-input mir rappreżentanti tal-pazjent lokali.
English: 25 mg Film-coated tablet
Maltese: Qawwa Għamla farmaċewtika
English: EU/1/07/383/001 Januvia
Maltese: Numru tal-MA (EU)
English: EMA/421074/2014 EMEA/H/C/000878
Maltese: EMEA/H/C/000878
English: The full EPAR for ChondroCelect 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 defects were on the femoral condyle and were between 1 and 5 cm2 in size.
Maltese: Id-difetti kienu fil-qarquċa tal-kondil femorali u jvarjaw minn 1 sa 5 cm2 fid-daqs.
English: Other information about ChondroCelect
Maltese: Aktar informazzjoni dwar ChondroCelect
English: This is a summary of the European public assessment report (EPAR) for ChondroCelect.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal ChondroCelect.
English: The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable.
Maltese: Is-CHMP ikkunsidra li ChondroCelect intwera li kien effettiv fil-kura ta' difetti fil-qarquċa tal-irkoppa ta' daqs bejn 1 u 5 cm2, u li l-profil tas-sigurtà kien ikkunsidrat bħala aċċettabbli.
English: ChondroCelect was also as effective as microfracture at improving symptoms.
Maltese: ChondroCelect kien ukoll effettiv daqs il-mikrofrattura fit-titjib tas-sintomi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ChondroCelect on 5 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal ChondroCelect fil-5 ta' Ottobru 2009.
English: ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Maltese: Sommarju tal-EPAR għall-pubbliku ċelloli tal-qarquċa awtologi kkaratterizzati b'mod xieraq espanduti ex vivo b'tali mod li juru l-marki speċifiċi tal-proteini (characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins).
English: The most common side effects with ChondroCelect (seen in more than 1 patient in 10) are arthralgia (joint pain), cartilage hypertrophy (overgrowth), joint crepitation (unusual crackling sounds) and swelling of the joint.
Maltese: L-effetti sekondarji l-aktar komuni b'ChondroCelect (li dehru f'iktar minn pazjent 1 minn kull 10) huma artalġija (uġigħ tal-ġogi), ipertrofija tal-qarquċa (kobor żejjed), tifqigħ tal-ġogi (ħsejjes ta' tifqigħ mhux normali) u nefħa tal-ġog.
English: Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Maltese: Minħabba li ChondroCelect huwa mediċina terapewtika avvanzata, huwa ġie evalwat mill-Kumitat għatTerapiji Avvanzati (CAT).
English: How has ChondroCelect been studied?
Maltese: Kif ġie studjat ChondroCelect?
English: A risk management plan has been developed to ensure that ChondroCelect is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li ChondroCelect jintuża bl-aktar mod sigur possibbli.
English: There was no clear evidence of a difference in the change of KOOS in patients treated with ChondroCelect and those treated with microfracture.
Maltese: Ma kien hemm ebda evidenza ċara ta' differenza fil-bidla tal-KOOS f'pazjenti kkurati b'ChondroCelect u dawk kkurati bil-mikrofrattura.
English: ChondroCelect must be administered by a qualified surgeon in a hospital.
Maltese: ChondroCelect għandu jingħata minn kirurgu kwalifikat ġewwa sptar.
English: ChondroCelect was more effective than microfracture at healing the defects in the cartilage.
Maltese: ChondroCelect kien iktar effettiv mill-mikrofrattura fil-fejqan tad-difetti fil-qarquċa.
English: What is ChondroCelect?
Maltese: X'inhu ChondroCelect?
English: ChondroCelect was compared with microfracture (a type of surgery used to treat defects in cartilage) in one main study involving 118 adult patients with symptoms caused by defects in their knee cartilage.
Maltese: Fi studju wieħed ewlieni li involva 118-il pazjent adult b'sintomi kkawżati mid-difetti fil-qarquċa ta' rkoppithom, ChondroCelect tqabbel ma' mikrofrattura (tip ta' intervent kirurġiku li jintuża biex jikkura difetti fil-qarquċa).
English: Why has ChondroCelect been approved?
Maltese: Għaliex ġie approvat ChondroCelect?
English: Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Ilkumpanija qed twettaq ukoll studju ta' osservazzjoni sabiex tikseb iżjed informazzjoni dwar is-sugurtà u l-effikaċja ta' ChondroCelect.
English: ChondroCelect is a suspension for implantation that contains cartilage cells.
Maltese: ChondroCelect huwa sospensjoni għall-impjantazzjoni li fiha ċ-ċelloli tal-qarquċa.
English: For the full list of all side effects reported with ChondroCelect, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'ChondroCelect, ara l-fuljett ta' tagħrif.
English: What is the risk associated with ChondroCelect?
Maltese: X'inhu r-riskju assoċjat ma' ChondroCelect?
English: It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.
Maltese: Il-kejl ewlieni tal-effikaċja kien kemm id-difetti fiequ tajjeb wara sena u l-bidla fl-Iskor Riżultanti talLeżjoni tal-Irkoppa u l-Osteoartrite (Knee Injury and Osteoarthritis Outcome Score (KOOS)) wara sena u tliet snin ta' kura.
English: What benefit has ChondroCelect shown during the studies?
Maltese: X'benefiċċju wera ChondroCelect matul l-istudji?
English: Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy.
Maltese: Il-pazjenti li jkunu qed jiġu kkurati b'ChondroCelect għandhom isegwu programm speċifiku ta' rijabilitazzjoni, inkluża l-fiżjoterapija.
English: Veterinary Medicines Division
Maltese: Diviżoni tal-Mediċini Veterinarji
English: 11 December 2014
Maltese: 11 ta' Diċembru 2014
English: International non-proprietary name (INN): spiramycin
Maltese: Denominazzjoni internazzjonali komuni (INN): spiramycin
English: 1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 1 Artikolu 35 tad-Direttiva 2001/82/KE, kif emendat 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Oral explanations were given on 9 September 2014.
Maltese: Spjegazzjonijiet orali ngħataw fid-9 ta' Settembru 2014.
English: Spiramycin is a macrolide antibiotic exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria which cause infections in cattle and pigs.
Maltese: Spiramycin huwa antibijotiku makrolidu li jeżerċita azzjoni batterjostatika kontra batterji talMikoplażma, Gram-negattivi u Gram-pożittivi li jikkawżaw infezzjonijiet f'ifrat u fi ħnieżer.
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Maltese: Il-prodotti mediċinali veterinarji Suanovil 20 soluzzjoni għall-injezzjoni u l-prodott ġeneriku tiegħu Spirovet huma soluzzjonijiet għall-injezzjoni li fihom 20 g spiramycin għal kull 100 ml, li jikkorrispondu għal 600 000 IU spiramycin għal kull ml.
English: Written explanations were provided by the applicants and marketing authorisation holders on 10 December 2012, 14 October 2013, 1 April 2014 and 10 June 2014.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mill-applikanti u d-detenturi talawtorizzazzjonijiet għat-tqegħid fis-suq fl-10 ta' Diċembru 2012, fl-14 ta' Ottubru 2013, fl-1 ta' April 2014 u fl-10 ta' Ġunju 2014.
English: The Committee appointed C. Ibrahim as rapporteur and B. Urbain as co-rapporteur.
Maltese: Ibrahim bħala relatur u lil B.
English: On 12 September 2012, Gemany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Maltese: Fit-12 ta' Settembru 2012, il-Ġermanja ppreżentat notifikazzjoni ta' referenza skont l-Artikolu 35 tadDirettiva 2011/82/KE lill-Aġenzija, fir-rigward ta' Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċjati u prodotti ġeneriċi tagħhom.
English: Opinion following an Article 351 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof
Maltese: Opinjoni wara referenza għal Artikolu 351 għal Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċjati u prodotti ġeneriċi tagħhom
English: The CVMP was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Maltese: Is-CVMP intagħlab jagħti opinjoni fuq l-indikazzjonijiet, reġimi ta' dożaġġ u perjodi ta' rtirar f'ifrat u fi ħnieżer, sabiex tiġi żgurata kura effikaċi u sabiex jitnaqqas irriskju ta' żvilupp ta' reżistenza antimikrobika għal spiramycin b'kunsiderazzjoni għad-dejta disponibbli kif ukoll biex jiġu armonizzati l-perjodi ta' rtirar f'ifrat u fi ħnieżer għall-prodotti kkonċernati.
English: Opinion following an Article 350F referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof EMA/745255/2014
Maltese: Opinjoni wara referenza għal Artikolu 350F għal Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċjati u prodotti ġeneriċi tagħhom
English: The referral started on 13 September 2012.
Maltese: Ir-referenza nbdiet fit-13 ta' Settembru 2012.
English: Therefore, on 9 September 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Maltese: Għalhekk, fid-9 ta' Settembru 2014, il-Kumitat adotta opinjoni pożittiva b'maġġoranza, u rrakkomanda varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċati u prodotti ġeneriċi tagħhom.
English: EU/2/03/038/005 ProteqFlu-Te
Maltese: EU/2/03/037/005 ProteqFlu
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml Clostridium tetani toxoid: ≥ 30 IU**/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Maltese: --1 Influenza A/equi-2/ Ohio/03 {H3N8}virus rikombinat tal-canarypox (vCP2242): ≥ 5.3 log10 FAID50*/ml Influenza A/equi-2/Richmond/1/07 {H3N8} virus rikombinat tal-canarypox (vCP3011): ≥ 5.3 log10 FAID50*/ml
English: 10 vials Zero days
Maltese: 10 fjali xejn
English: ** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur.
Maltese: ** titlu tal-antikorp antitossiku indott wara tilqim ripetut fis-sera tal-fenek tal-Indi skont il-Ph.Eur
English: Route of administration
Maltese: Metodu ta' amministra zzjoni
English: Horses Intramuscular use vial (glass) 1 ml
Maltese: * Il-kontenut tal-vCP iċċekjat bil-FAID50 globali (doża infettiva florexxenti ta' prova 50 %) u r-ratio qPCR bejn vCP.
English: EU (MA) Number Invented name
Maltese: Fjala (talhġieġ)
English: On 5 December 2018, Pfizer Europe MA EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fyzoclad, for the treatment of a number of inflammatory diseases.
Maltese: Fil-5 ta' Diċembru 2018, Pfizer Europe MA EEIG għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Fyzoclad, għall-kura ta' numru ta' mard infjammatorju.
English: What is Fyzoclad?
Maltese: X'inhu Fyzoclad?
English: Fyzoclad is a medicine that contains the active substance adalimumab.
Maltese: Fyzoclad huwa mediċina li fiha s-sustanza attiva adalimumab.
English: The reference medicine for Fyzoclad is Humira.
Maltese: Il-mediċina ta' referenza għal Fyzoclad hija Humira.
English: Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab) EMA/866697/2018
Maltese: 13 ta' Diċembru 2018 EMA/10633/2019
English: Fyzoclad was developed as a ‘biosimilar' medicine.
Maltese: Fyzoclad ġie żviluppat bħala mediċina ‘bijosimili'.
English: The company presented laboratory studies comparing Fyzoclad to its reference medicine Humira in terms of structure, purity and biological activity.
Maltese: Il-kumpanija ppreżentat studji fil-laboratorju li jqabblu Fyzoclad mal-mediċina ta' referenza tiegħu Humira f'termini ta' struttura, purità u attività bijoloġika.
English: What was Fyzoclad expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Fyzoclad?
English: Fyzoclad was expected to work in the same way as the reference medicine, Humira.
Maltese: Fyzoclad kien mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Humira.
English: The active substance in Fyzoclad and Humira, adalimumab, is a monoclonal antibody (a type of protein) that has
Maltese: Is-sustanza attiva f'Fyzoclad u f'Humira, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' sustanza fil-ġisem imsejħa fattur tan-nekrożi tat-tumur (TNF).
English: • uveitis (inflammation of the layer beneath the white of the eyeball) and paediatric uveitis.
Maltese: • uveite (infjammazzjoni tas-saff ta' taħt l-abjad tal-boċċa tal-għajn) u uveite pedjatrika.
English: Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Fyzoclad (adalimumab)
English: The application was withdrawn while the CHMP was still evaluating the initial documentation provided by the company.
Maltese: L-applikazzjoni ġiet irtirata waqt li s-CHMP kien għadu qiegħed jevalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija.
English: • juvenile idiopathic arthritis (disease causing inflammation in the joints);
Maltese: • artrite idjopatika ġovanili (marda li tikkawża infjammazzjoni fil-ġogi);
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor bil-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi);
English: INFORMATION IN BRAILLE PROCORALAN 7.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PROCORALAN 7.5 mg
English: INFORMATION IN BRAILLE PROCORALAN 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PROCORALAN 5 mg
English: EU/1/05/316/001 [EU/1/05/316/002] [EU/1/05/316/003] [EU/1/05/316/004] [EU/1/05/316/005] [EU/1/05/316/006] [EU/1/05/316/007]
Maltese: [EU1/05/316/002] [EU1/05/316/003] [EU1/05/316/004] [EU1/05/316/005] [EU1/05/316/006] [EU1/05/316/007]
English: 92284 Suresnes cedex - France
Maltese: Suresnes cedex- Franza
English: - The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).
Maltese: Procoralan 7.5 mg: pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti għal 8.085 mg ivabradine hydrochloride) - Is-sustanzi l-oħra fil-qalba tal-pillola huma: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), u fil-kisja tal-pillola: hypromellose (E 470), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470B), iron oxide isfar (E 172), iron oxide aħmar (E 172).
English: Preferred Term
Maltese: Terminu ppreferut
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to, <1/10); uncommon (≥1/1,000 to, <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapporatati waqt provi kliniċi u huma kklassifikati bl-użu ta' din ilfrekwenza: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10000 sa <1/1000); rari ħafna (<1/10000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Other medicines and Procoralan
Maltese: Mediċini oħra u Procoralan
English: Do not take Procoralan if you are breast-feeding (see “Do not take Procoralan”).
Maltese: Tiħux Procoralan jekk qed tredda' (ara taħt “Tiħux Procoralan”).
English: Procoralan (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Maltese: Procoralan (ivabradine) huwa mediċina għall-mard tal-qalb li jintuża għall-kura ta': - Anġina pectoris sintomatika stabbli (li tikkaġuna uġigħ fis-sider) f'adulti li r-rata tat-taħbit tal-qalb tagħhom hija 70 taħbita jew aktar fil-minuta.
English: * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Maltese: * Il-frekwenza hija kkalkolata minn provi kliniċi għal avvenimenti avversi mikxufin minn rapport spontanju
English: Ivabradine is eliminated with a main half-life of 2 hours (70-75% of the AUC) in plasma and an effective half-life of 11 hours.
Maltese: Eliminazzjoni Ivabradine jitneħħa b'half-life prinċipali ta' sagħtejn (70-75% ta' l-AUC) fil-plażma u half-life effettiva ta' 11-il siegħa.
English: Servier Italia S.p.A. Tel: +39 (06) 669081
Maltese: Tel: +39 (06) 669081
English: In a pooled analysis of all the Phase II/III double blind controlled clinical trials with a duration of at least 3 months including more than 40,000 patients, the incidence of atrial fibrillation was 4.86% in ivabradine treated patients compared to 4.08% in controls, corresponding to a hazard ratio of 1.26, 95% CI [1.15-1.39].
Maltese: II/III b'durata ta' mill-inqas 3 xhur li jinkludu aktar minn 40,000 pazjent, l-inċidenza ta' fibrillazzjoni atrijali kienet ta' 4.86% f'pazjenti kkurati b'ivabradine meta mqabbel ma' 4.08 % filkontrolli, u dan jikkorrispondi għal proporzjon ta' periklu ta' 1.26, 95% CI [1.15-1.39].
English: Servier Polska SP. Z O.O.
Maltese: Italia Servier Italia S.p.A.
English: The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95%CI [0.75;0.90] - p<0.0001) apparent within 3 months of initiation of treatment.
Maltese: L-istudju wera tnaqqis relattiv fir-riskju klinikament u statistikament sinifikanti ta' 18% fir-rata talendpoint kompost primarju tal-mortalità kardjovaskulari u rikoveru l-isptar għal taħżin fl-insuffiċjenza tal-qalb (proporzjon tal-periklu: 0.82, 95%CI [0.75;0.90] - p<0.0001) li deher fi żmien 3 xhur mill-bidu tal-kura.
English: Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Maltese: Procoralan 7.5 mg pilloli huma pilloli miksija b'rita, kulur is-salamun, triangulari, imnaqqxin b'“7.5” fuq naħa waħda u b' fuq in-naħa l-oħra.
English: Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Maltese: Procoralan 5 mg pilloli miksija b'rita Procoralan 7.5 mg pilloli miksija b'rita ivabradine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/008-014
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/316/008-014