FrancophonIA/ELRC3.0 huggingface dataset:
English: ‘Prevora 100mg/ml Dental Solution is an antiseptic solution which is applied topically to the dentition of patients for the prevention of coronal and root caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers or those with 3 or more caries at the start of the treatment plan).
Maltese: ‘Prevora 100 mg/ml Soluzzjoni Dentali hija soluzzjoni antisettika li tiġi applikata fuq is-snien ta' pazjenti għall-prevenzjoni ta' taħsir koronali u tal-għeruq f'pazjenti adulti b'riskju għoli ta' taħsiriet fis-snien (eż. min ibati minn xerostomia jew dawk li għandhom 3 taħsiriet jew aktar fil-bidu tal-pjan ta' kura).
English: Subsequent applications being based upon clinical judgment of caries risk by the dental professional.
Maltese: Applikazzjonijiet sussegwenti huma bbażati fuq il-ġudizzju kliniku tar-riskju ta' karje mill-profesjonista tas-snien.
English: A double-blind, randomised, multi-centred, controlled trial conducted in adults at risk of dental caries.
Maltese: Prova kkontrollata, b'aktar minn ċentru wieħed, randomizzata, double-blinded li saret f'adulti b'riskju ta' karje fis-snien.
English: When risk (as measured by the number of cavities at screening) is added to the ANOVA model to account for the bimodal distribution of disease in this study population at both screening and during the study, an overall clinical effect of 36.8% at p = 0.04 is observed.
Maltese: Meta jiżdied riskju (kif imkejjel min-numru ta' taħsiriet fl-iskrinjar) mal-mudell ANOVA għaddistribuzzjoni bimodali tal-marda fil-popolazzjoni ta' dan l-istudju kemm fl-iskrinjar kif ukoll waqt listudju, jidher effett kliniku totali ta' 36.8% għal p = 0.04.
English: These were patients between the ages of 11 and 13 years with evidence of past or current caries experience and elevated levels of salivary Streptococcus mutants.
Maltese: Dawn kienu pazjenti bejn l-etajiet ta' 11 u 13-il sena b'evidenza ta' esperjenza ta' karje preżenti jew li kienet hemm minn qabel u livelli elevati ta' mutanti ta' Streptococcus salivari.
English: This is a Phase III, multi-centre, placebo-controlled, double-blinded, prospective study.
Maltese: Dan huwa studju prospettiv, double blinded, ikkontrollat bi plaċebo, b'aktar minn ċentru wieħed, ta' Fażi
English: The comparison of caries increment was active versus placebo.
Maltese: It-tqabbil taż-żieda fil-karje kien attiv kontra plaċebo.
English: Scientific conclusions
Maltese: IPPREŻENTATI
English: Grounds for positive opinion and amendment of the summary of product characteristics and package leaflet
Maltese: U RAĠUNIJIET GĦAL OPINJONI POŻITTIVA U EMENDI TAS-SOMMARJU TAL-KARATTERISTIĊI
English: The product is a topical two-stage chlorhexidine solution.
Maltese: Il-prodott huwa soluzzjoni topikali ta' chlorhexidine b'żewġ stadji.
English: in high risk patients;
Maltese: PACS f'pazjenti b'riskju għoli;
English: The CHMP assessing the apparent “reverse” treatment effect for at low-risk population explained this issue by the relative absence of high risk participants (those with 3+ cavities at screening) in the placebo groups where as the high-risk population (at risk population) had a higher baseline rate of cavities.
Maltese: Is-CHMP meta vvaluta l-effett apparenti “bil-maqlub” tal-kura għall-popolazzjoni b'riskju baxx spjega din il-kwistjoni bin-nuqqas relattiv ta' parteċipanti b'riskju għoli (dawk bi 3+ taħsiriet fl-iskrinjar) fil-gruppi bi plaċebo fejn il-popolazzjoni b'riskju għoli (popolazzjoni f'riskju) kellha rata tal-linja ta' bażi ogħla ta' taħsiriet.
English: The two clinical studies initially submitted by the MAH to support the proposed indication were:
Maltese: Iż-żewġ studji kliniċi sottomessi inizjalment mill-MAH biex jappoġġja lindikazzjoni proposta kienu:
English: Considering the resistant and opportunistic infections, this study showed no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans after treatment with Prevora over one year in adult patients.
Maltese: Dwar infezzjonijiet reżistenti u opportunistiċi, dan l-istudju ma wera l-ebda reżistenza sinifikanti għal Streptococcus mutans jew infezzjonijiet opportunistiċi b'Candida albicans wara kura ta' aktar minn sena bi Prevora f'pazjenti adulti.
English: Dental caries is a bacterial based chronic disease.
Maltese: Il-karje tas-snien hija marda kronika b'bażi batterjali.
English: As defined by the primary endpoint, this study showed no significant difference between active and placebo.
Maltese: Kif definit mill-punt finali primarju, dan l-istudju ma wera l-ebda differenza sinifikanti bejn attiv u plaċebo.
English: Although the results may not be statistically significant, there was no evidence of an interaction, and thus there are sufficient statistical evidence to grant an indication for all surfaces in the high-risk population, and not just root surfaces.
Maltese: Għalkemm ir-riżultati jistgħu ma jkunux statistikament sinifikanti, ma kienx hemm evidenza ta' interazzjoni, u għalhekk hemm evidenza statistika biżżejjed biex tingħata indikazzjoni għall-uċuh kollha fil-popolazzjoni b'riskju għoli, u mhux biss għall-uċuh tal-egħruq.
English: To be used in dental offices only by dental professionals.'
Maltese: Għandu jintuża biss f'uffiċċji tad-dentisti minn professjonisti tas-snien.'
English: The primary endpoint was the number of new cavities (coronal plus root surfaces) per participant, as measured at the end-of-study visit.
Maltese: Il-punt finali primarju kien in-numru ta' taħsiriet ġodda (tal-kuruni u tal-uċuh tal-għeruq) għal kull parteċipant, kif imkejla fil-vista tal-aħħar tal-istudju.
English: • the assessment of all available data submitted by the MAH in particular the result from the PACS
Maltese: • il-valutazzjoni tad-dejta kollha disponibbli sottomessa mill-MAH b'mod partikolari r-riżultat mill
English: EMA/499771/2018
Maltese: (axalimogene filolisbac) EMA/499771/2018
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Lulju 2018 EMA/499771/2018 EMEA/H/C/004473
English: What is Raligize?
Maltese: X'inhu Raligize?
English: Raligize is a cancer medicine containing the active substance axalimogene filolisbac.
Maltese: Raligize huwa mediċina ta' kontra l-kanċer li fih is-sustanza attiva axalimogene filolisbac.
English: The active substance in Raligize, axalimogene filolisbac, consists of a bacterium, Listeria monocytogenes, that has been modified so it can produce a protein that stimulates the immune (defence) system to attack cancer cells.
Maltese: Is-sustanza attiva f'Raligize, axalimogene filolisbac, tikkonsisti minn batterju, Listeria monocytogenes, li ġie modifikat sabiex jipproduċi proteina li tistimula s-sistema immuni (ta' difiża) biex tattakka ċċelluli tal-kanċer.
English: On 10 July 2018, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raligize, for the treatment of cancer of the cervix (the neck of the womb).
Maltese: Fl-10 ta' Lulju 2018, FGK Representative Service GmbH għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għallawtorizzazzjoni għat-tqegħid fis-suq għal Raligize, għall-kura ta' kanċer taċ-ċerviċi (l-għonq tal-ġuf).
English: Because Raligize is an advanced therapy medicine, it was assessed on behalf of the CHMP by the Committee for Advanced Therapies (CAT).
Maltese: Minħabba li Raligize huwa mediċina għal terapija avvanzata, dan ġie vvalutat f'isem is-CHMP millKumitat għat-Terapiji Avvanzati (CAT).
English: What was Raligize expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Raligize?
English: Raligize was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Raligize ġie żviluppat bħala tip ta' mediċina għal terapija avvanzata msejħa "prodott ta' terapija talġeni".
English: The bacteria in Raligize have had a gene inserted in their DNA so they can produce a new substance containing one of the HPV proteins, E7, linked to part of another protein, listeriolysin O. The linked protein is able to stimulate the immune system against E7.
Maltese: Il-batterji f'Raligize kellhom ġene mdaħħal fid-DNA tagħhom sabiex ikunu jistgħu jipproduċu sustanza ġdida li jkun fiha waħda mill-proteini tal-HPV, E7, marbuta ma' parti ta' proteina oħra, listeriolysin O.
English: The company provided data from one main study involving 50 women with advanced cervical cancer, including cancer that had come back after other treatment or had spread elsewhere in the body.
Maltese: Il-kumpanija pprovdiet data minn studju ewlieni wieħed li involva 50 mara b'kanċer taċ-ċerviċi avvanzat, inkluż kanċer li kien irritorna wara kura oħra jew li kien infirex xi mkien ieħor fil-ġisem.
English: The application was withdrawn while the CAT was still evaluating the initial documentation provided by the company.
Maltese: L-applikazzjoni ġiet irtirata waqt li s-CAT kien għadu qiegħed jevalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija.
English: Cervical cancer is mainly caused by long-lasting infection with certain strains of the human papillomavirus (HPV), which produce proteins in infected cells that stimulate them to grow and become cancerous.
Maltese: Il-kanċer taċ-ċerviċi jiġi kkawżat prinċipalment minn infezzjoni li ddum b'ċerti razez ta' vajrus talpapilloma uman (HPV), li jipproduċu proteini f'ċelluli infettati li jistimulawhom biex jikbru u jsiru kanċerużi.
English: It was to be available as a concentrate for making up an infusion (drip) to be given into a vein.
Maltese: Dan kellu jkun disponibbli bħala konċentrat biex issir infużjoni (dripp) li tingħata ġo vina.
English: When Raligize is given to the patient, the bacteria are taken up by cells of the immune system where they stimulate it to recognize the E7 protein and attack and kill cancer cells that contain it.
Maltese: Il-proteina marbuta kapaċi tistimula s-sistema immuni kontra E7.
English: --1 Lyophilisate (live attenuated) Canine distemper virus, strain Bio CDV 11/A
Maltese: Lijofilizzat (attenwat ħaj) Canine distemper virus, strejn CDV Bio 11/A
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Maltese: Canine parainfluenza type 2 virus, strejn CPiV-2-Bio 15 103.1 -105.1 TCID50* * Tissue culture infectious dose 50%
English: The full EPAR for ReFacto AF 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: ReFacto AF contains the active substance moroctocog alfa.
Maltese: ReFacto AF fih issustanza attiva moroctocog alfa.
English: ReFacto AF is given by injection into a vein over several minutes.
Maltese: ReFacto AF jingħata permezz ta' injezzjoni fil-vina li ddum diversi minuti.
English: The CHMP noted that ReFacto AF was comparable to ReFacto, the original form of the medicine.
Maltese: Is-CHMP innota li ReFacto AF kien komparabbli ma' ReFacto, il-forma oriġinali tal-mediċina.
English: This is a summary of the European public assessment report (EPAR) for ReFacto AF.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal ReFacto AF.
English: The human coagulation factor VIII in ReFacto AF is not extracted from human blood but 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 coagulation factor VIII.
Maltese: Il-fattur ta' koagulazzjoni VIII uman f'ReFacto AF mhuwiex estratt mid-demm tal-bniedem iżda jiġi prodott permezz ta' metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti': hija magħmula minn ċellola li tkun irċeviet ġene (DNA), li tagħmilha kapaċi jipproduċu l-fattur ta' koagulazzjoni VIII uman.
English: The active substance in ReFacto AF, moroctocog alfa, works in the body in the same way as human factor VIII.
Maltese: Is-sustanza attiva f'ReFacto AF, il-moroctocog alfa, taħdem fil-ġisem blistess mod bħall-fattur VIII uman.
English: It also carried out two main studies looking at the effectiveness of ReFacto AF: the first looked at the prevention and treatment of bleeding episodes in 94 previously treated patients and the second looked at the prevention of bleeding in 22 patients having surgery.
Maltese: Il-kumpanija wettqet ukoll żewġ studji prinċipali li jħarsu lejn l-effikaċja ta' ReFacto AF: lewwel wieħed ħares lejn il-prevenzjoni u l-kura ta' inċidenti ta' fsada f'94 pazjent ikkurati minn qabel u t-tieni wieħed ħares lejn il-prevenzjoni ta' fsada fi 22 pazjent li kellhom intervent kirurġiku.
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs.
Maltese: Pazjenti b'emofilja A m'għandhomx fattur VIII, proteina meħtieġa għal koagulazzjoni normali taddemm, u dan iwassal biex ikollhom fsada mill-ewwel u jista' jkollhom problemi bħal fsada fil-ġogi, ilmuskoli u l-organi interni.
English: How is ReFacto AF used?
Maltese: X'hinu ReFacto AF?
English: ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder).
Maltese: ReFacto AF jintuża għall-kura u l-prevenzjoni ta' fsada f'pazjenti b'emofilja A (disturb ta' fsada ereditarju).
English: The European Commission granted a marketing authorisation valid throughout the European Union for ReFacto AF on 13 April 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal ReFacto AF fit-13 ta' April 1999.
English: The dose and the frequency of treatment depend on whether ReFacto AF is used to treat or prevent bleeding, the seriousness of the condition, the extent and location of the bleeding or the type of surgery, and the patient's bodyweight.
Maltese: Id-doża u l-frekwenza talkura jiddependu fuq jekk ReFacto AF jintużax għall-kura jew għall-prevenzjoni tal-fsada, il-gravità talkundizzjoni, il-firxa u post tal-fsada jew it-tip ta' kirurġija, u l-piż tal-ġisem tal-pazjent.
English: The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
Maltese: L-istudji wrew li ReFacto AF kien sikur u effettiv daqs ReFacto fil-prevenzjoni u l-kura ta' inċidenti ta' fsada f'pazjenti b'emofilja A.
English: ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies.
Maltese: ReFacto AF ġie awtorizzat bħala ReFacto f'April 1999, biex jintuża f'pazjenti b'emofilja A li kienu jew ma kinux ikkurati minn qabel, abbażi tar-riżultati ta' tliet studji prinċipali.
English: What is the risk associated with ReFacto AF?
Maltese: X'inhu r-riskju assoċjat ma' ReFacto AF?
English: How has ReFacto AF been studied?
Maltese: Kif ġie studjat ReFacto AF?
English: The most common side effects with ReFacto AF (seen in more than 1 patient in 10) are headache, cough, pain in the joints and fever.
Maltese: L-effetti sekondarji l-aktar komuni b'ReFacto AF (li deher f'iktar minn pazjent wieħed minn kull għaxra) huma wġigħ ta' ras, sogħla, uġigħ fil-ġogi u deni.
English: Why has ReFacto AF been approved?
Maltese: Għaliex ġie approvat ReFacto AF?
English: ReFacto AF must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins.
Maltese: ReFacto AF m'għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għall-fattur ta' koagulazzjoni VIII uman, jew għal xi sustanza oħra, jew għall-proteini tal-ħemster.
English: These included removal of the use of a protein called albumin, which is produced from human blood, from the manufacturing process.
Maltese: Dawn kienu jinkludu t-tneħħija tal-użu ta' proteina msejħa albumina, li hija prodotta mid-demm uman, mill-proċess ta' manifatturar.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refacto AF have been included in the summary of product characteristics and the package leaflet.
Maltese: Ir-rakkomandazzjonijiet u l-prekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam talkura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' ReFacto AF ġew inklużi fis-sommarju talkaratteristiċi tal-prodott u fil-fuljett ta' tagħrif.
English: MA (EU) Number
Maltese: Numru tal-MA (UE) Isem (ivvintat)
English: Pack size
Maltese: L-Ewwel Ippakkjar
English: Further information on Ivabradine Anpharm can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
Maltese: Aktar informazzjoni dwar Ivabradine Anpharm tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
English: Ivabradine Anpharm received a marketing authorisation valid throughout the EU on 8 September 2015.
Maltese: Ivabradine Anpharm irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fit8 ta' Settembru 2015.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Maltese: Kien effettiv daqs atenolol (imblokkatur tar-riċetturi Beta) fi studju ta' 939 pazjent u effettiv daqs amlodipine (mediċina oħra użata għall-kura tal-anġina) fi studju ta' 1,195 pazjent.
English: Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Maltese: Ivabradine Anpharm jiġi bħala pilloli (5 u 7.5 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Results showed that it was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Ivabradine Anpharm died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Maltese: Ir-riżultati urew li kien aktar effikaċi minn plaċebo fil-prevenzjoni tal-mewt minħabba mard fil-qalb jew fil-vini jew dħul fl-isptar minħabba l-aggravar tal-insuffiċjenza kardijaka: 24.5 % (793 minn 3,241) tal-pazjenti kkurati b'Ivabradine Anpharm mietu jew iddaħħlu l-isptar minħabba aggravar tal-insuffiċjenza kardijaka, meta mqabbla ma' 28.7 % (937 minn 3,264) tal-pazjenti li ngħataw plaċebo.
English: The active substance in Ivabradine Anpharm, ivabradine, works by blocking the ‘If currents' in the sinus node, the natural ‘pacemaker' that controls the heart's contractions and regulates the heart rate.
Maltese: Is-sustanza attiva f'Ivabradine Anpharm, ivabradine, taħdem billi timblokka l-'kurrenti If' fin-nodi tas-sinus, il-'pacemaker' naturali li jikkontrolla l-kontrazzjonijiet tal-qalb u jirregola r-rata ta' taħbit tal-qalb.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Maltese: Il-bradikardija (rata baxxa tat-taħbit tal-qalb) hija komuni (tista' taffettwa sa persuna 1 minn kull 10).
English: As for all medicines, data on the use of Ivabradine Anpharm are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ivabradine Anpharm hija ssorveljata kontinwament.
English: It also concluded that Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile.
Maltese: Ikkonkluda wkoll li Ivabradine Anpharm kien effikaċi kontra insuffiċjenza kardijaka fit-tul u li għandu profil ta' sigurtà aċċettabbli.
English: Ivabradine Anpharm is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Maltese: Ivabradine Anpharm huwa mediċina tal-qalb li tintuża għall-kura tas-sintomi ta' anġina stabbli fit-tul (uġigħ fis-sider, ix-xedaq u d-dahar, ikkaġunat minn sforzi fiżiċi) f'adulti b'marda tal-arterja koronarja (marda fil-qalb ikkaġunata minn imblukkar fl-arterji u fil-vini tad-demm li jwasslu d-demm sal-muskolu tal-qalb).
English: Ivabradine Anpharm was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Maltese: Ivabradine Anpharm tqabbel ukoll ma' plaċebo fi studju ewlieni wieħed li inkluda aktar minn 6,500 pazjent b'insuffiċjenza kardijaka fit-tul minn moderata sa gravi.
English: Other information about Ivabradine Anpharm
Maltese: Informazzjoni oħra dwar Ivabradine Anpharm
English: Ivabradine Anpharm must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Maltese: Ivabradine Anpharm ma għandux jintuża fuq pazjenti li r-rata tat-taħbit tal-qalb tagħhom waqt l-irpoż tkun taħt is-70 taħbita fil-minuta, li jkollhom pressjoni tad-demm baxxa ħafna, diversi tipi ta' disturbi fil-qalb (inklużi xokkijiet kardjoloġiċi, disturbi ritmiċi, attakk tal-qalb, insuffiċjenza kardijaka instabbli jew akuta (għall-għarrieda) u anġina instabbli) jew problemi gravi fil-fwied.
English: This authorisation was based on the authorisation granted to Procoralan in 2005 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Procoralan fl-2005 (‘kunsens infurmat').
English: However, a fifth study in 728 patients showed that adding Ivabradine Anpharm to amlodipine did not provide an additional benefit.
Maltese: Madankollu, il-ħames studju f'728 pazjent wera li Ivabradine Anpharm miżjud ma' amlodipine ma pprovdiex benefiċċju addizzjonali.
English: A sixth study compared Ivabradine Anpharm with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Maltese: Is-sitt studju qabbel lil Ivabradine Anpharm ma' plaċebo f'19,102 pazjenti b'mard koronarju tal-arterji u mingħajr insuffiċjenza kardijaka klinika.
English: The medicine is used in patients who have a normal heart rhythm and whose heart rate is at least 70 beats per minute.
Maltese: Il-mediċina tintuża f'pazjenti li għandhom ritmu tal-qalb normali u li r-rata ta' taħbit tal-qalb tagħhom hija tal-inqas 70 taħbita fil-minuta.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Maltese: F'pazjenti li għandhom ‘il fuq minn 75 sena, tista' tintuża doża inizjali iżjed baxxa ta' 2.5 mg darbtejn kuljum.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Ivabradine Anpharm compared with placebo (3.4% vs 2.9% yearly incidence rates).
Maltese: F'dan l-istudju, sottogrupp speċifiku ta' pazjenti li kellhom anġina sintomatika kellhom żieda żgħira iżda sinifikanti fir-riskju kkombinat ta' mewt kardjovaskulari jew attakk tal-qalb mhux fatali b'Ivabradine Anpharm meta mqabbel ma' plaċebo (rati ta' inċidenza ta' 3.4 % fis-sena meta mqabbla ma' 2.9 %).
English: Ivabradine Anpharm contains the active substance ivabradine.
Maltese: Ivabradine Anpharm fih is-sustanza attiva ivabradina.
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Maltese: Il-kejl ewlieni tal-effikaċja kien tnaqqis fir-riskju ta' mewt minħabba problemi kardijaċi u infart kardijaku mhux fatali.
English: How is Ivabradine Anpharm used?
Maltese: Ivabradine Anpharm?
English: What are the risks associated with Ivabradine Anpharm?
Maltese: X'inhuma r-riskji assoċjati ma' Ivabradine Anpharm?
English: For the full list of all side effects reported with Ivabradine Anpharm, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji rrappurtati b'Ivabradine Anpharm, ara l-fuljett ta' tagħrif.