FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy of combination therapy on the primary endpoint was consistent on the comparison to individual monotherapy and across the subgroups of age, ethnic origin, geographical region, aetiology (IPAH /hPAH and PAH-CTD).
Maltese: L-effikaċja tat-terapija kombinata fuq il-punt ta' tmiem primarju kienet konsistenti fit-tqabbil għall-monoterapija individwali u fis-sottogruppi ta' etajiet, oriġini etnika, reġjun ġeografiku, etjoloġija (IPAH /hPAH u PAH-CTD). L-effett kien sinifikanti kemm għall-pazjenti FC II kif ukoll dawk FC III.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza ta'galactose, iddefiċjenza ta' Lapp lactase jew assorbiment mhux siwi ta' glucose -galactose m'għandhomx jieħdu din il-mediċina.
English: It is used to treat pulmonary arterial hypertension (PAH) in adults.
Maltese: Huwa jintuża biex jittratta pazjenti b'ipertensjoni arterjali tal-pulmun (PAH) fl-adulti.
English: Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets.
Maltese: Daqs tal-pakkett b'folji ta' doża waħda ta' 10x1 jew 30x1 pillola miksija b'rita.
English: Information from longer term non-placebo controlled studies (ARIES-E and AMBITION (combination with tadalafil)) is also included below.
Maltese: Hawn taħt hija inkluża wkoll informazzjoni minn studji mhux ikkontrollati bi plaċebo għal żmien itwal (ARIES-E u AMBITION (kombinazzjoni ma' tadalafil)).
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited
Maltese: GlaxoSmithKline (Ireland) Limited
English: Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Maltese: Għalhekk id-doża ta' ambrisentan għandha tkun limitata għal 5 mg darba kuljum meta jingħata flimkien ma' cyclosporine A (ara sezzjoni 4.2).
English: Package leaflet: Information for the user Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets ambrisentan
Maltese: Informazzjoni għall-utent Volibris 5 mg pilloli miksija b'rita Volibris 10 mg pilloli miksija b'rita ambrisentan
English: The combined mean exposure was approximately 145 ± 80 weeks, and the maximum exposure was approximately 295 weeks.
Maltese: L-esponiment medju kkombinat kien madwar 145 ± 80 ġimgħat, u lesponiment massimu kien madwar 295 ġimgħa.
English: Uncommon side effects:
Maltese: Effetti sekondarji mhux komuni:
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 4.5).
Maltese: Pazjenti fuq trattament b'ambrisentan għandhom ikunu ssorveljati mill-qrib meta jinbeda trattament b'rifampicin (ara sezzjonijiet 4.4 u 4.5).
English: The cumulative incidence of serum aminotransferase abnormalities >3xULN in all Phase 2 and 3 studies (including respective open label extensions) was 17 of 483 subjects over a mean exposure duration of 79.5 weeks.
Maltese: L-inċidenza kumulattiva ta' anormalitajiet ta' aminotransferase fis-serum >3xULN fl-istudji kollha f'Fażi 2 u 3 (li jinkludu estensjonijiet open label rispettivi) kienu 17 minn 483 individwu matul medja ta' espożizzjoni ta' 79.5 ġimgħa.
English: The distribution of ambrisentan into red blood cells is low, with a mean blood:plasma ratio of 0.57 and 0.61 in males and females, respectively.
Maltese: Id-distribuzzjoni ta' ambrisentan f'ċambriseħomor tad-demm hi baxxa, b'medja proporzjonali demm:plażma ta' 0.57 u 0.61 fi rġielu nisa rispettivament.
English: PVC/PVDC/aluminium foil blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PVDC/fojl tal-aluminjum.
English: adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
Maltese: L-inċidenza ta' anemija żdiedet meta ambrisentan ġie ddożat f'kombinazzjoni ma' tadalafil (frekwenza ta' avveniment avvers ta' 15%), meta mqabbel mal-inċidenza ta' anemija meta ambrisentan u tadalafil ingħataw bħala monoterapija (7% u 11%, rispettivament).
English: Volibris is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.
Maltese: Volibris mhux irrakkomandat għal tfal u adolexxenti b'età inqas minn 18-il sena peress li s-sigurtà u leffettività mhux magħrufa f'dan il-grupp ta' età.
English: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
Maltese: D-23843 Bad Oldesloe
English: Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets
Maltese: Volibris 5 mg pilloli miksija b'rita Volibris 10 mg pilloli miksija b'rita
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.5 and 5.2).
Maltese: Pazjenti fuq trattament b'ambrisentan għandhom ikunu ssorveljati mill-qrib meta jinbeda trattament b'rifampicin (ara sezzjonijiet 4.5 u 5.2).
English: In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea and nasal congestion.
Maltese: F'voluntiera b'saħħithom, dożi waħedhom ta' 50 u 100 mg (5 sa 10 darbiet id-doża massima rakkommandata) kienu assoċjati ma' uġigħ ta' ras, fawra, sturdament dardir u sadda fl-imnieħer.
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Volibris, once a day.
Maltese: Jekk tieħu cyclosporine A, tieħux aktar minn pillola ta' 5 mg ta' Volibris darba kuljum.
English: The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1200 patients with PAH (see section 5.1).
Maltese: Is-sigurtà ta' ambrisentan ġiet evalwata bħala monoterapija/jew f'kombinazzjoni fi studji kliniċi ta' aktar minn 1200 pazjent b'PAH (ara sezzjoni 5.1).
English: Volibris 10 mg film-coated tablet (tablet) is a deep pink, oval, convex tablet engraved with ‘GS' on one face and ‘KE3' on the other.
Maltese: Il-pillola miksija b'rita ta' Volibris 10 mg (pillola) hija roża skur, ovali, u konvessa b"GS' imnaqqxa fuq naħa waħda u ‘KE3' fuq in-naħa l-oħra.
English: Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Maltese: Ġiet osservata iperplasja fl-għadam spirali etmojde tal-imnieħer fil-ħofra tal-imnieħer ta' firien ittrattati b'ambrisentan, b'livelli ta' esponiment 3-darbiet aktar mill-AUC kliniku.
English: Volibris tablets contain the azo colouring agent Allura red AC Aluminium Lake (E129), which can cause allergic reactions.
Maltese: Il-pilloli ta' Volibris fihom is-sustanza azo li tagħti l-kulur Allura red AC Aluminium Lake (E129), li tista' tikkawża reazzjonijiet allerġiċi.
English: Adverse reactions identified from 12 week placebo controlled clinical trial data are included below by system organ class and frequency.
Maltese: L-effetti avversi li nstabu minn studju kliniku ta' 12-il ġimgħa kkontrollat bi plaċebo huma inklużi taħt skont is-sistema tal-klassi tal-organi u lfrekwenza.
English: Volibris 5 mg film-coated tablets Each tablet contains 5 mg of ambrisentan.
Maltese: Matul dan iż-żmien ħamsin filmija tal-pazjenti kienu żiedu ambrisentan minn 5 mg sa 10 mg.
English: The primary endpoint was the time to first occurrence of a clinical failure event, defined as: - death, or - hospitalisation for worsening PAH, - disease progression; - unsatisfactory long-term clinical response.
Maltese: Il-punt ta' tmiem primarju kien iż-żmien sal-ewwel okkorrenza ta' avveniment ta' insuffiċjenza klinika, iddefinit bħala: - mewt, jew - rikoveru l-isptar għall-PAH li tmur għall-agħar, - progressjoni tal-marda; - rispons kliniku fit-tul mhux sodisfaċenti.
English: Uncommon3,8
Maltese: C02KX02
English: Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see sections 4.3, 4.4 and 5.3).
Maltese: Nisa li jkunu fuq ambrisentan għandhom jingħataw parir fuq ir-riskju ta' ħsara lil fetu u jekk ikun hemm tqala għandu jinbeda trattament ieħor (ara s-sezzjonijiet 4.3, 4.4 u 5.3).
English: EU/1/08/451/004 30 film-coated tablets
Maltese: EU/1/08/451/003 10 pilloli miksija b'rita EU/1/08/451/004 30 pillola miksija b'rita
English: The in vitro plasma protein binding of ambrisentan was, on average, 98.8% and independent of concentration over the range of 0.2 - 20 microgram/ml.
Maltese: L-irbit mal-proteini fil-plażma in vitro ta' ambrisentan kien, bħala medja, 98.8% u indipendenti minn konċentrazzjoni tul il-medda ta'
English: In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI: 47% to 92%).
Maltese: 001), il-proporzjon ta' riskju wera tnaqqis ta' 80% (95% CI: minn 47% sa 92%).
English: Teл.
Maltese: Tqalligħ
English: Male fertility
Maltese: Fertilità fl-irġiel
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in hemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies.
Maltese: Tnaqqis medju mil-linja bażi (li jvarja minn 0.9 sa 1.2 g/dl) fil-konċentrazzjonijiet tal-emoglobina ppersista sa 4 snin ta' trattament b'ambrisentan fl-estensjoni open-label fit-tul tal-istudji kliniċi pivitali ta' Fażi 3. Wara t-tqegħid fis-suq, kienu rrappurtati każijiet ta' anemija li jeħtieġu trasfużjoni ta' ċelluli tad-demm (ara sezzjoni 4.8).
English: • Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Maltese: • Ambrisentan jimblokka s-sottotip tar-riċettur ETA, li jinstab l-aktar fuq ċelluli lixxi talmuskolu vaskulari u ċelluli tal-muskolu tal-qalb.
English: A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.
Maltese: Fil-gruppi ta' trattament ta' ambrisentan total ta' 17-il pazjent (6.5%) kellhom nuqqas fl-emoglobina ta' ≥15% mil-linja bażi u li waqgħat taħt illimitu l-aktar baxx tan-normal
English: If you are allergic to soya, do not use this medicine (see section 2 ‘Don't take Volibris').
Maltese: Jekk inti allerġiku għas-sojja, tużax din il-mediċina (ara sezzjoni 2 ‘Tieħux Volibris').
English: No dose adjustment is required in patients over the age of 65 (see section 5.2).
Maltese: Ma hemmx għalfejn aġġustament fid-doża f'pazjenti 'il fuq minn 65 sena (ara s-sezzjoni 5.2).
English: Volibris 10 mg film-coated tablets Each tablet contains 10 mg of ambrisentan.
Maltese: Volibris 10 mg pilloli miksija b'rita Kull pillola fiha 10 mg ta' ambrisentan.
English: Ambrisentan
Maltese: Treddigħ
English: Patient reminder card should include the following key elements:
Maltese: Il-punti ta' tmiem sekondarji kienu ttestjati:
English: Peripheral oedema, fluid retention and headache (including sinus headache, migraine) were the most common adverse reactions observed with ambrisentan.
Maltese: Edima periferali, żamma ta' fluwidu u uġigħ ta' ras (inkluż uġigħ ta' ras mis-sinus, emigranja) kienu laktar reazzjonijet avversi komuni osservati b'ambrisentan.
English: Read the information under ‘Breast-feeding'
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Disease progression
Maltese: TAL-PRODOTT MEDIĊINALI
English: Eye disorders Blurred vision, visual impairment Not known4
Maltese: Disturbi fl-għajnejn Vista mċajpra, indeboliment viżiv Mhux magħruf
English: Hepatic impairment
Maltese: Konġestjoni nażali
English: Dyspnoea
Maltese: Dijarea
English: 9 Rash includes rash erythematous, rash generalised, rash papular and rash pruritic
Maltese: Raxx jinkludi raxx bi ħmura, raxx ġeneralizzat, raxx papulari u raxx bil-ħakk
English: Hepatobiliary disorders Hepatic injury (see section 4.4)
Maltese: It-treddigħ huwa kontra-indikat f'pazjenti li jieħdu ambrisentan (ara sezzjoni 4.3).
English: Deep-pink, oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side.
Maltese: Pillola miksija b'rita, roża skur, ovali, konvessa, b'"GS" imnaqqxa fuq naħa waħda u "KE3" fuq innaħa l-oħra.
English: Similarly, co-administration with tadalafil did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Maltese: Bl-istess mod, l-għoti flimkien ma' tadalafil ma affettwatx il-farmakokinetika ta' ambrisentan (ara sezzjoni 4.5).
English: Very common2
Maltese: ANNESS II
English: However, multiple doses of ambrisentan had no clinically relevant effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Maltese: Madankollu, dożi multipli ta' ambrisentan ma kellhom l-ebda effett rilevanti klinikament fuq l-espożizzjoni ta' cyclosporine A, u ma hemm l-ebda bżonn ta' aġġustament fid-doża ta' cyclosporine A.
English: Chest pain/discomfort
Maltese: Uġigħ/skonfort fis-sider
English: Vial (glass) 2 ml (150 mg/ml) 6 (6 x 1) vials + 6 (6 X 1) syringes + 12 (6 X 2) needles (multipack)
Maltese: 6 (6 x 1) kunjetti + 6 (6 x 1) siringi + 12-il (6 x 2) labra (pakkett multiplu)
English: Vial (glass) 2 ml (150 mg/ml) 1 vial + 1 syringe +
Maltese: Kunjett (ħġieġ) 2 mL (150 mg/ml) Kunjett wieħed + siringa waħda +
English: EU (MA) Number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (UE) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Vial (glass) 2 ml (150 mg/ml) 2 (2 X 1) vials + 2 (2 X 1) syringes + 4 (2
Maltese: 2 (2 x 1) kunjetti +2 (2 x 1) siringi + 4 (2 x 2) labriet (pakkett multiplu)
English: It is available as tablets (5mg).
Maltese: Jiġi f'pilloli (5mg).
English: The full EPAR for Desloratadine ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Desloratadine ratiopharm jinsab fis-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Desloratadine ratiopharm is a ‘generic medicine'.
Maltese: Desloratadine ratiopharm huwa ‘mediċina ġenerika'.
English: The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Maltese: Id-doża rakkomandata għal adulti u adoloxxenti (minn 12-il sena 'l fuq) hija 5 mg darba kuljum.
English: EPAR summary for the public desloratadine
Maltese: Sommarju tal-EPAR għall-pubbliku desloratadina
English: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine ratiopharm on 13 January 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Desloratadine ratiopharm fil-13 ta' Jannar 2012.
English: Desloratadine ratiopharm is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Maltese: Desloratadine ratiopharm jintuża biex itaffi s-sintomi tar-rinite allerġika (infjammazzjoni fil-passaġġi nażali kkawżata minn allerġija, pereżempju minn riħ tal-ħuxlief (hay fever) jew urtikarja (kundizzjoni fil-ġilda kkawżata minn allerġija, b'sintomi li jinkludu ħakk u ħorriqija).
English: The active substance in Desloratadine ratiopharm, desloratadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Desloratadine ratiopharm, id-desloratadina, hija sustanza antistaminika.
English: This is a summary of the European public assessment report (EPAR) for Desloratadine ratiopharm.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Desloratadine ratiopharm.
English: The CHMP concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been shown to have comparable quality and to be bioequivalent to Aerius.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li l-kwalità ta' Desloratadine ratiopharm hija kumparabbli mal-prodott mediċinali bijoekwivalenti Aerius.
English: Desloratadine ratiopharm is a medicine containing the active substance desloratadine.
Maltese: Desloratadine ratiopharm huwa mediċina li fiha s-sustanza attiva desloratadina.
English: Because Desloratadine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Maltese: Billi Desloratadine ratiopharm huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza Aerius.
English: Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Ġaladarba Desloratadine ratiopharm huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Desloratadine ratiopharm?
Maltese: X'inhu Desloratadine ratiopharm?
English: What are the benefits and risks of Desloratadine ratiopharm?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Desloratadine ratiopharm?
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Maltese: Meta r-riċetturi jkunu imblokkati, l-istamina ma jkunx jista' jkollha effett, u dan iwassal għal tnaqqis fis-sintomi tal-allerġija.
English: Other information about Desloratadine ratiopharm
Maltese: Aktar tagħrif dwar Desloratadine ratiopharm
English: How has Desloratadine ratiopharm been studied?
Maltese: Kif ġie studjat Desloratadine ratiopharm?
English: The Committee recommended that Desloratadine ratiopharm be given marketing authorisation.
Maltese: Il-Kumitat irrakkomanda li Desloratadine ratiopharm jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Aerius, il-benefiċċji huma akbar mir-riskji identifikati.
English: How is Desloratadine ratiopharm used?
Maltese: Kif jaħdem Desloratadine ratiopharm?
English: This means that Desloratadine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Maltese: Dan ifisser li Desloratadine ratiopharm jixbah lill‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Aerius.
English: Immediate Packaging
Maltese: 14-il kapsula iebsa
English: The full EPAR for Cubicin 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 summary was last updated in 12-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 12-2017.
English: Cubicin daptomycin
Maltese: Cubicin daptomiċina
English: Cubicin contains the active substance daptomycin.
Maltese: Cubicin fih is-sustanza attiva daptomiċina.
English: • bacteraemia (infection of the blood) caused by S. aureus.
Maltese: • Batteremija (infezzjoni fid-demm) ikkawżata minn S. aureus.
English: The most common side effects with Cubicin (seen in between 1 and 10 patients in 100) are infections caused by fungi (moulds and yeasts), urinary tract infections (infection of the structures that carry urine), Candida infection (a fungal infection), anaemia (low red blood cell counts), anxiety, insomnia (difficulty sleeping), dizziness, headache, hypertension (high blood pressure), hypotension (low blood pressure), gastrointestinal and abdominal pain (belly ache), nausea (feeling sick), vomiting, constipation, diarrhoea, flatulence (gas), bloating and distension (feeling as if the tummy is full), rash, pruritus (itching), pain in the limbs (arms or legs), infusion site reactions, pyrexia (fever), asthenia (weakness), abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage).
Maltese: L-effetti sekondarji l-aktar komuni b'Cubicin (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma infezzjonijiet ikkawżati minn fungi (moffa u ħmira), infezzjonijiet fl-apparat urinarju (infezzjoni talistrutturi li jġorru l-awrina), infezzjoni ta' Candida (infezzjoni fungali), anemija (għadd baxx ta' ċelloli ħomor tad-demm), ansjetà, insomnja (diffikultà fl-irqad), sturdament, uġigħ ta' ras, pressjoni għolja, pressjoni baxxa, uġigħ gastrointestinali u addominali, nawseja, rimettar, stitikezza, dijarea, gass flistonku, nefħa u distensjoni (tħoss żaqqek mimlija), raxx, prurite (ħakk), uġigħ fil-ġogi (fl-idejn jew fis-saqajn), reazzjonijiet fis-sit tal-injezzjoni, piressija (deni), astenija (debbulizza), testijiet tal-fwied mhux normali u livelli għoljin ta' enzima msejħa CPK fid-demm (indikatur ta' ħsara fil-muskoli).
English: Other information about Cubicin
Maltese: Informazzjoni oħra dwar Cubicin
English: This is a summary of the European public assessment report (EPAR) for Cubicin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cubicin.
English: Why is Cubicin approved?
Maltese: Għalxiex ġie approvat Cubicin?
English: The second study in children and adolescents involved 73 patients with bacteraemia caused by S. aureus.
Maltese: Fit-tieni studju fuq tfal u adolexxenti ħadu sehem 73 pazjent b'batteremija kkawżata minn S. aureus.
English: The active substance in Cubicin, daptomycin, is an antibiotic that belongs to the group ‘lipopeptides'.
Maltese: Is-sustanza attiva f'Cubicin, daptomiċina, hija antibijotiku li jappartjeni għall-grupp tal-‘lipopeptidi'.
English: • right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus (S. aureus) in adults.
Maltese: • endokardite infettiva fuq in-naħa tal-lemin (infezzjoni tal-kisja jew tal-valvijiet tan-naħa tal-lemin tal-qalb) ikkawżata mill-batterju Staphylococcus aureus (S. aureus)) fl-adulti.
English: Serious side effects include hypersensitivity (allergic) reactions, eosinophilic pneumonia (infection of the lungs), drug rash with eosinophilia and systemic symptoms (DRESS, a severe reaction affecting the skin, blood and internal organs), angioedema (rapid swelling of deeper skin tissues) and rhabdomyolysis (breakdown of muscle fibres).
Maltese: Effetti sekondarji serji jinkludu reazzjonijiet ta' ipersensittività (allerġiċi), pulmonite eosinofilika (infezzjoni tal-pulmuni), raxx minħabba l-mediċina b'sintomi ta' eosinofilja u sistemiċi (DRESS, reazzjoni severa li taffettwa l-ġilda, id-demm u l-organi interni), anġjoedema (nefħa rapida tat-tessuti fil-fond tal-ġilda) u rabdomijoliżi (tkissir tal-fibri tal-muskoli).
English: Treatment was successful in 88% (227 out of 257) of the patients receiving Cubicin compared with 86% (114 out of 132) receiving standard treatment.
Maltese: Il-kura rnexxiet fi 88% (227 minn 257) tal-pazjenti li kienu qed jirċievu Cubicin meta mqabbel ma' 86% (114 minn 132) ta' dawk li kienu qed jirċievu kura standard.
English: What are the risks associated with Cubicin?
Maltese: X'inhuma r-riskji assoċjati ma' Cubicin?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cubicin on 19 January 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cubicin fid-19 ta' Jannar 2006.
English: Standard treatments comprised use of antibiotics such as vancomycin, a penicillin (including oxacillin, cloxacillin, flucloxacillin and nafcillin) or a cephalosporin.
Maltese: Il-kura standard kienet tinkludi l-użu ta' antibijotiċi bħal vankomiċina, peniċillina (fosthom oxacillin, cloacacillin, flucloxacillin u nafcillin) jew ċefalosporina.