FrancophonIA/ELRC3.0 huggingface dataset:
English: The review of Xofigo was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment) with Zytiga and prednisone/prednisolone.
Maltese: Ir-rieżami ta' Xofigo sar mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) talEMA wara data minn studju kliniku ssuġġeriet li l-pazjenti li jingħataw Xofigo flimkien ma' Zytiga u prednisone/prednisolone jistgħu jkunu f'riskju li jmutu qabel u kellhom aktar ksur minn pazjenti li ngħataw plaċebo (kura finta) ma' Zytiga u prednisone/prednisolone.
English: Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy).
Maltese: Xofigo m'għandux jintuża ma' terapiji tal-kanċer sistemiċi oħra, ħlief kuri biex iżommu livelli mnaqqsa ta' ormoni tar-raġel (terapija tal-ormoni).
English: • The prostate cancer medicine Xofigo can increase the risk of having fractures.
Maltese: • Il-mediċina kontra l-kanċer tal-prostata Xofigo tista' żżid ir-riskju li jkollok ksur.
English: A possible increased risk of death was also observed in a clinical trial investigating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer.
Maltese: Ġie osservat riskju miżjud possibbli ta' mewt fi prova klinika li investigat Xofigo flimkien ma' abiraterone acetate u prednisone/prednisolone f'pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni asintomatiku jew ftit sintomatiku.
English: • Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone.
Maltese: • Xofigo huwa kontraindikat flimkien ma' abiraterone acetate u prednisone/prednisolone.
English: • In mildly symptomatic patients, the benefit of treatment should be carefully assessed against its risks, considering that high osteoblastic activity is likely to be required for treatment benefit (see below for more information).
Maltese: • F'pazjenti ftit sintomatiċi, il-benefiċċju tal-kura għandu jiġi vvalutat b'attenzjoni meta mqabbel mar-riskji tagħha, filwaqt li jiġi kkunsidrat li aktarx tkun meħtieġa attività osteoblastika għolja għall-benefiċċji tal-kura (ara taħt għal aktar informazzjoni).
English: • Concurrent use of bisphosphonates or denosumab has been found to reduce the incidence of fractures in patients treated with Xofigo.
Maltese: • L-użu konkurrenti tal-bisfosfonati jew denosumab instab li jnaqqas l-inċidenza ta' ksur f'pazjenti kkurati b'Xofigo.
English: Also, having Xofigo together with the cancer medicine Zytiga and a corticosteroid medicine (prednisone or prednisolone) for prostate cancer could possibly increase the risk of death.
Maltese: Barra minn hekk, jekk tieħu Xofigo flimkien mal-mediċina kontra l-kanċer Zytiga u mediċina kortikosterojde (prednisone jew prednisolone) għall-kanċer tal-prostata, dan jista' possibbilment iżid ir-riskju ta' mewt.
English: • Before starting and during treatment with Xofigo, an assessment of patients' bone status (e.g. by scintigraphy, bone mineral density measurement) and risk of fractures (e.g. osteoporosis, fewer than 6 bone metastases, medication increasing fracture risk, low body mass index) should be performed.
Maltese: • Qabel il-bidu u waqt il-kura b'Xofigo, għandha ssir valutazzjoni tal-istatus tal-għadam tal-pazjenti (eż. permezz ta' skintigrafija, kejl tad-densità minerali tal-għadam) u tar-riskju ta' ksur (eż. osteoporożi, inqas minn 6 metastasi fl-għadam, medikazzjoni li żżid ir-riskju ta' ksur, indiċi talmassa tal-ġisem baxx).
English: The review of Xofigo was initiated on 1 December 2017 at the request of the European Commission, Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-rieżami ta' Xofigo nbeda fl-1 ta' Diċembru 2017 fuq talba mill-Kummissjoni Ewropea, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: In addition, Xofigo should not be started in the first 5 days following the last dose of abiraterone and prednisone/prednisolone.
Maltese: Barra minn hekk, Xofigo m'għandux jinbeda fl-ewwel 5 ijiem wara l-aħħar doża ta' abiraterone u prednisone/prednisolone.
English: • Your doctor will not use the combination of Xofigo and the other two medicines for prostate cancer.
Maltese: • It-tabib tiegħek mhuwiex ser juża l-kombinazzjoni ta' Xofigo u ż-żewġ mediċini l-ora għall-kanċer tal-prostata.
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Maltese: halofantrine, pentamidine, cisapride, erythromycin ġol-vini).
English: Date of latest renewal: 31/08/2010
Maltese: Data tal-aħħar tiġdid: 31/08/2010
English: Servier Austria GmbH Tel: +43 (1) 524 39 99
Maltese: Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99
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: 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: Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Maltese: Procoralan jista' jikkaġunalek fenomeni viżivi mudwali temporanji (luminożità temporanja fil-kamp viżiv, ara “Effetti Sekondarji li jista' jkollu”).
English: - Elderly: no pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥ 65 years) or very elderly patients (≥ 75 years) and the overall population (see section 4.2).
Maltese: - Anzjani: ma kienx hemm differenza farmakokinetika (AUC u Cmax) bejn anzjani (≥ 65 sena) jew anzjani ħafna (≥ 75 sena) u l-popolazzjoni inġenerali (ara sezzjoni 4.2).
English: Excipient with known effect: 63.91 mg lactose monohydrate Procoralan 7.5 mg film-coated tablets
Maltese: Eċċipjent b'effett magħruf: 63.91 mg lactose monohydrate Procoralan 7.5 mg pilloli miksija b'rita.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/10/2005
Maltese: Data tal-ewwel awtorizzazzjoni: 25/10/2005
English: A randomised, double blind, placebo controlled study was performed in 116 paediatric patients (17 aged [6-12[months, 36 aged [1-3[ years and 63 aged [3-18[ years) with CHF and dilated cardiomyopathy (DCM) on top of optimal background treatment.
Maltese: Sar studju randomizzat, double blind, ikkontrollat bi plaċebo f'116-il pazjent pedjatriku (17 li għandhom [6-12[-il xahar, 36 li għandhom [1-3[ snin u 63 li għandhom [3-18[ snin) b'CHF jew b'kardjomijopatija dilatata (DCM) flimkien ma' kura ta' sfond ottimali. 74 ingħataw ivabradine
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 talqalb tagħhom hija 70 taħbita jew aktar fil-minuta.
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 % fil-kontrolli, u dan jikkorrispondi għal proporzjon ta' periklu ta' 1.26, 95%
English: CYP3A4 inhibitors and inducers are liable to interact with ivabradine and influence its metabolism and pharmacokinetics to a clinically significant extent.
Maltese: CYP3A4 jaħdmu iżjed jista' jkollhom interazzjoni ma' ivabradine u jinfluwenzaw il-metaboliżmu u l farmakokinetika tiegħu b'mod klinikament sinifikanti.
English: Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Maltese: Kura ta' insuffiċjenza kronika tal-qalb Ivabradine huwa indikat f'insuffiċjenza kronika tal-qalb tal-klassi NYHA II sa IV b'disfunzjoni sistolika, f'pazjenti b'ritmu regolari normali u li r-rata ta' qalbhom hija ≥ 75 bpm, flimkien ma' terapija standard inkluż terapija beta-blocker jew meta terapija beta-blocker tkun kontra-indikata jew mhux tollerata (ara sezzjoni 5.1).
English: The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Maltese: dawn il-prodotti mediċinali huwa kontraindikat (ara sezzjoni 4.3).
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”
English: - Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole,
Maltese: - Mediċini mhux kardjovaskulari li jtawwlu l-QT (eż. pimozide, ziprasidone, sertindole, mefloquine,
English: Package leaflet: information for the patient 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: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Maltese: Pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti ghal 8.085 mg bħala ivabradine hydrochloride)
English: Muscle spasms
Maltese: Popolazzjoni speċjali
English: One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Maltese: Pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti għal 5.390 mg ivabradine hydrochloride)
English: Children Procoralan is not intended for use in children and adolescents younger than 18 years.
Maltese: Tfal Procoralan mhuwiex intenzjonat sabiex jintuża fi tfal u adoloxxenti ta' inqas minn 18-il sena.
English: Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Maltese: palpitazzjonijiet, żieda fl-uġigħ fis-sider) jew fibrillazzjoni atrijali sostnuta (tip ta' taħbita tal-qalb irregolari), jew anormalità ta' elettrokardjogramma (ECG) imsejħa 'sindromu QT imtawwal', - jekk għandek sintomi ta' għejja, sturdament jew qtugħ ta' nifs (dan jista' jfisser li għandek il-qalb qed tħabbat bil-mod ħafna),
English: Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Maltese: Procoralan 7.5 mg: pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti għal
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6505 adult patients with stable chronic CHF (for ≥ 4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF ≤ 35%) and a resting heart rate ≥ 70 bpm.
Maltese: NYHA tal-klassi II sa IV, fi frazzjoni mnaqqsa tat-tfigħ mill-ventrikolu tax-xellug (LVEF ≤ 35%) u rata tal-qalb waqt il-mistrieħ ta' ≥ 70 bpm.
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Maltese: - mediċini li jtawwlu l-QT għall-kura ta' problemi fir-ritmu tal-qalb jew kundizzjonijiet oħra bħal: - quinidine, disopyramide, ibutilide, sotalol, amiodarone (għall-kura ta' problemi fir-ritmu tat taħbit tal-qalb) - bepridil (kura għal angina pectoris) - xi mediċini għall-kura ta' ansjetà, skiżofrenija jew psikożi oħra (bħal pimozide, ziprasidone,
English: Procoralan 7.5 mg film-coated tablets
Maltese: Procoralan 7.5 mg pilloli miksija b'rita.
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
Maltese: - jekk qed tieħu mediċini għall-kura ta' infezzjoni fungali (bħal ketoconazole, itraconazole), antibijotiċi ta' tip macrolide (bħal josamycin, clarithromycin, telithromycin jew erythtromycin meħuda mill-ħalq), mediċini għall-kura ta' infezzjonijiet b'HIV (bħal nelfinavir, ritonavir) jew nefazodone (mediċina għall-kura tad-dipressjoni) jew diltiazem, verapamil (użat għall-pressjoni tad-demm għolja jew anġina pectoris); - jekk inti mara li jista' jkollha t-tfal u ma tużax kontraċettivi affidabbli; - jekk int tqila jew qed tipprova toħroġ tqila;
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs iddoża, jiġifieri nofs pillola ta' 5 mg ta' Procoralan 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
English: Procoralan 5 mg film-coated tablets
Maltese: Procoralan 5 mg pilloli miksija b'rita.
English: Procoralan 5 mg film-coated tablets EU/1/05/316/001-007
Maltese: EU/1/05/316/001-007
English: How does Procoralan work?
Maltese: Kif jaħdem Procoralan?
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Maltese: Pillola miksija b'rita, kulur is-salamun, triangolari, imnaqqxa b'“7.5” fuq naħa waħda u b' fuq innaħa l-oħra.
English: Excipients
Maltese: Ġestjoni
English: McDonald (2005) Conversion
Maltese: Konverżjoni McDonald (2005)
English: Placebo (n=171)
Maltese: Plaċebo (n=171)
English: CDMS Conversion
Maltese: Konverżjoni CDMS
English: Recommended Titration (% of final dose)
Maltese: Titrazzjoni Rakkomandata (% tad-doża finali)
English: Cox's Proportional Hazard Ratio [95% CI]
Maltese: Proporzjon ta' Periklu Proporzjonali ta' Cox [95% CI]
English: Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Maltese: Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne L-Iżvizzera
English: Weeks 1-2
Maltese: Ġimgħat 1-2
English: Merck Serono S.A. - Corsier-sur-Vevey Route de Fenil - Z.I.B.
Maltese: Merck Serono SA - Corsier-sur-Vevey Route de Fenil - Z.I.B.
English: Weeks 5+
Maltese: Ġimgħat 5+
English: Log-Rank p-value
Maltese: Log-Rank valur p
English: Parameter Statistics
Maltese: Statistika talParametru
English: Weeks 3-4
Maltese: Ġimgħat 3-4
English: Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB07
Maltese: Immunostimulanti, Interferons, Kodiċi ATC: LO3AB07
English: Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
Maltese: Gustav Mahlerplein 102 1082 MA Amsterdam L-Olanda
English: Date of latest renewal: 04 May 2008
Maltese: Data tal-aħħar tiġdid: 04 ta' Mejju 2008
English: • Serious allergic (hypersensitivity) reactions.
Maltese: • Reazzjonijiet allerġiċi serji (ipersensittivita).
English: CH-1804 Corsier-sur-Vevey Switzerland or
Maltese: CH-1804 Corsier-sur-Vevey L-Iżvizzera jew
English: Treatment Comparison Rebif 44 mcg tiw versus Placebo
Maltese: Paragun tal-Kura Rebif 44 mcg tiw kontra Plaċebo
English: • The active substance is interferon beta-1a.
Maltese: • Is-sustanza attiva hi interferon beta-1a.
English: 8.8 micrograms tiw
Maltese: 8.8 mikrogrammi tiw
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Maltese: Abbażi ta' data dwar l-annimali (ara sezzjoni 5.3), hemm il-possibbiltà ta' riskju miżjud ta' abort spontanju.
English: Pruritus, rash, erythematous rash, maculo-papular rash, alopecia*
Maltese: Ħakk, raxx, raxx eritematuż, raxx makulo-papulari, alopeċja*
English: The estimated apparent half-life is 50 to 60 hours, which is in line with the accumulation observed after multiple dosing.
Maltese: Il-half-life apparenti stmata hija ta' 50-60 siegħa, li hija konformi malakkumulazzjoni osservata wara dożi multipli.
English: Neutropenia, lymphopenia, leukopenia, thrombocytopenia, anaemia
Maltese: Newtropenija, limfopenija, lewkopenija, tromboċitopenija, anemija
English: • Hold RebiDose at a right angle (90 degrees) to the injection site.
Maltese: • Żomm RebiDose f'angolu rett (90 grad) għas-sit ta' injezzjoni.
English: Primary progressive multiple sclerosis
Maltese: Sklerożi multipla progressiva primarja
English: Rebif contains benzyl alcohol
Maltese: Rebif fih benzyl alcohol
English: 22 micrograms tiw
Maltese: 22 mikrogramma tiw
English: First demyelinating event
Maltese: L-ewwel avveniment demyelinating
English: Merck Europe B.V.
Maltese: OĦRAJN Merck Europe B.V.
English: 44 micrograms tiw
Maltese: 44 mikrogramma tiw
English: Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome* (class label for interferon beta products, see section 4.4), pancytopenia*
Maltese: Mikroanġjopatija trombotika li tinkludi tromboċitopenija purpura trombotika/sindrome uremiku emolitiku* (tikketta tal-klassi għal prodotti li fihom interferon beta; ara sezzjoni 4.4), panċitopenija*
English: INFORMATION IN BRAILLE rebif 44/0.5
Maltese: rebif 44/0.5
English: • Current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Maltese: • Depressjoni u/jew b'ideat ta' suwiċidju (ara sezzjonijiet 4.4 u 4.8).
English: Interferons are a group of endogenous glycoproteins endowed with immunomodulatory, antiviral and antiproliferative properties.
Maltese: Interferons huma grupp ta' glikoproteini endoġeni li għandhom effetti immunodulatorji, kontra lviruses u antiproliferattivi.
English: • Alcohol wipes or similar.
Maltese: • Ċarutta bl-alkoħol jew simili.
English: Rebif (interferon beta-1a) shares the same amino acid sequence with endogenous human interferon beta.
Maltese: Rebif (interferon beta-1a) jaqsam l-istess sekwenza amino aċida ma' interferon beta uman endoġenu.
English: Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/L.
Maltese: Soluzzjoni ċara għal opalexxenti, b'pH ta' 3.5 sa 4.5 u osmolarita ta' 250 to 450 mOsm/L
English: • Epileptic seizures
Maltese: • Puplesiji epilettiċi
English: Hepatic failure* (see section 4.4), autoimmune hepatitis*
Maltese: Insuffiċjenza tal-fwied* (ara sezzjoni 4.4), epatite awtoimmuni*
English: The following definitions apply to the frequency terminology used hereafter: 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), frequency not known (cannot be estimated from the available data).
Maltese: Id-definizzjonijiet li ġejjin japplikaw għat-terminoloġija tal-frekwenza li tintuża minn hawn 'il quddiem: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Maltese: Każijiet ta' sindromu nefrotiku b'nefropatiji sottostanti differenti li jinkludu glomerulosklerożi segmentali fokali li tikkollassa (FSGS), marda b'tibdil minimu (MCD), glomerulonefrite membranoproliferattiva (MPGN) u glomerulopatija membranuża (MGN) ġew irrappurtati matul ilkura bi prodotti li fihom interferon-beta.
English: Secondary progressive multiple sclerosis
Maltese: Sklerożi multipla sekondarja progressiva
English: Thromboembolic events* Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Avvenimenti tromboemboliċi* Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni:
English: • Insomnia (sleeping difficulty)
Maltese: • Insomnia (diffikulta biex torqod)
English: Biological response markers (e.g., 2',5'-OAS activity, neopterin and beta 2-microglobulin) are induced by interferon beta-1a following subcutaneous doses administered to healthy volunteer subjects.
Maltese: Markaturi tar-rispons bijoloġiku (eż., 2',5'-attività OAS, neopterin u beta 2-microglobulin) huma indotti minn interferon beta-1a wara dożi taħt il-ġilda mogħtija lil voluntiera b'saħħithom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 May 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04 ta' Mejju 1998
English: Cessation of therapy with Rebif should be considered (see sections 4.3 and 4.8).
Maltese: Il-waqfien mit-terapija ma' Rebif għandu jkun ikkunsidrat (ara sezzjonijiet 4.3 u 4.8).
English: INFORMATION IN BRAILLE rebif 8.8 rebif 22
Maltese: rebif 8.8 rebif 22
English: Mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid and sodium hydroxide for pH adjustment and water for injections.
Maltese: Mannitol, poloxamer 188, L-methionine, benzyl alkohol, sodium acetate, acetic acid u sodium hydroxide għal aġġustament tal-pH u ilma għall-injezzjoni.