FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Stronghold Plus?
Maltese: X'inhuma r-riskji assoċjati ma' Stronghold Plus?
English: A laboratory study with cats artificially infected with heartworm showed Stronghold Plus to be effective for the prevention of heartworm disease.
Maltese: Studju fil-laboratju bi qtates li kienu infestati b'mod artifiċjali bil-heartworm urew li Stronghold Plus hu effettiv għall-prevenzjoni tal-marda tal-heartworm.
English: Stronghold Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Maltese: Stronghold Plus kien effettiv daqs il-mediċina l-oħra u naqqas l-għadd ta' briegħed b'aktar minn 95 %.
English: The most common side effects with Stronghold Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling saliva.
Maltese: L-effetti sekondarji l-aktar komuni bi Stronghold Plus (li jistgħu jaffettwaw sa qattus 1 minn kull 100) huma alopeċja ħafifa sa moderata (jaqa' x-xagħar) fis-sit tal-applikazzjoni, eritema (ħmura tal-ġilda) u tlegħib ta' bżiq.
English: Why is Stronghold Plus approved?
Maltese: Għaliex ġie approvat Stronghold Plus?
English: Stronghold Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Maltese: Stronghold Plus joqtol il-briegħed u xi qurdien f'24 siegħa u dan ikompli jaħdem għal 5 ġimgħat kontra l-briegħed u għal 4 sa 5 ġimgħat kontra l-qurdien (skont it-tip).
English: Stronghold Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that live inside the body.
Maltese: Il-qtates ġew ikkurati bi Stronghold Plus kull xahar għal 3 xhur jew b'mediċina oħra kontra l-parassiti, li kien fiha l-imidakloprid u l-moksidektin.
English: The effectiveness of Stronghold Plus was investigated in a field study in cats naturally infested with fleas.
Maltese: L-effikaċja ta' Stronghold Plus ġiet investigata fi studju fuq il-post fi qtates li kienu infestati b'mod naturali bil-briegħed.
English: A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.
Maltese: Studju fil-laboratorju bi qtates infestati b'qamel li jigdem wera li s-selamektin jelimina l-qamel li jigdem għal 42 jum wara l-kura meta mqabbel ma' qtates ikkurati bil-plaċebo.
English: Stronghold Plus is harmful after swallowing.
Maltese: X'inhu Stronghold Plus u għal xiex jintuża?
English: Stronghold Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Maltese: Stronghold Plus jiġi bħala soluzzjoni spot-on fi tliet qawwiet differenti u jista' jinkiseb biss b'riċetta ta' tabib.
English: The medicine can be used:
Maltese: Il-mediċina tista' tintuża:
English: Sarolaner is effective against ticks and fleas.
Maltese: Is-sarolaner hu effettiv kontra l-qurdien u l-briegħed.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Stronghold Plus's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Stronghold Plus huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Cats were treated with Stronghold Plus monthly for 3 months or another medicine, containing fipronil.
Maltese: Il-qtates ġew ikkurati bi Stronghold Plus kull xahar għal 3 xhur jew b'mediċina oħra, li kien fiha l-fipronil.
English: A second field study was conducted in cats naturally infested with ticks.
Maltese: Sar studju ieħor fuq il-post fi qtates li kienu infestati b'mod naturali bil-qurdien.
English: The full EPAR for Azomyr 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: Azomyr is a medicine containing the active substance desloratadine.
Maltese: Azomyr huwa mediċina li fiha s-sustanza attiva desloratadine.
English: The active substance in Azomyr, desloratadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Azomyr, desloratadine, hija sustanza antiistaminika.
English: It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.
Maltese: Jiġi bħala pillola ta' 5 mg, 2.5 mg u bħala pilloli li jinħallu fil-ħalq ta' 5 mg (jiddewbu fil-ħalq), mediċina ta' 0.5 mg/ml u soluzzjoni orali ta' 0.5 mg/ml.
English: This is a summary of the European public assessment report (EPAR) for Azomyr.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Azomyr.
English: This summary was last updated in 10-2014.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'10-2014.
English: In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Maltese: Fl-adulti u l-adoloxxenti, l-iktar effetti sekondarji komuni huma l-għeja (1.2%), nixfa fil-ħalq (0.8%) u wġigħ ta' ras (0.6%).
English: The dose in children depends on their age.
Maltese: Id-doża fit-tfal tvarja skont l-età.
English: In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Maltese: Fiż-żewġ studji dwar l-urtikarja, wara trattament ta' sitt ġimgħat b'Azomyr, it-tnaqqis fil-punteġġ tas-sintomi kien bejn 58 u 67%, meta mqabbel ma' 40 u 33% f'pazjenti li kienu qed jieħdu plaċebo.
English: In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
Maltese: Fit-tfal ta' inqas minn sentejn, l-iktar effetti sekondarji komuni huma d-dijarea (3.7%), id-deni (2.3%) u l-insomnja (nuqqas ta' ngħas;
English: Other information about Azomyr
Maltese: Informazzjoni oħra dwar Azomyr:
English: Azomyr has also been studied in 416 patients with urticaria.
Maltese: Azomyr ġie studjat ukoll f'416-il pazjent b'urtikarja.
English: What is Azomyr?
Maltese: X'inhu Azomyr?
English: Adults and adolescents can use any form of the medicine.
Maltese: L-adulti u l-adoloxxenti jistgħu jieħdu kwalunkwe forma tal-mediċina.
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, histamine ma tistax twettaq l-effett tagħha, u dan iwassal għal tnaqqis fis-sintomi tal-allerġija.
English: In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Maltese: Fir-rinite allerġika, ir-riżultati kollha meħuda flimkien urew li trattament ta' ġimagħtejn b'Azomyr 5mg wassal għal tnaqqis medju fil-punteġġ tas-sintomi ta' bejn 25 u 32% waqt li fil-pazjenti li kienu qed jingħataw plaċebo kien hemm tnaqqis ta' bejn 12 u 26%.
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 jew aktar) hi ta' 5 mg darba kuljum.
English: Azomyr 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: Azomyr jintuża biex itaffi s-sintomi ta' rinite allerġika (infjammazzjoni tal-passaġġi nażali kkawżati b'allerġija pereżempju minn hay fever jew allerġija għal akari tat-trab) jew urtikarja (kundizzjoni filġilda kkawżata minn allerġija, b'sintomi li jinkludu ħakk u ħorriqija).
English: Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Maltese: B'kollox saru 8 studji fuq Azomyr li fihom ħadu sehem madwar 4,800 pazjent adult u adoloxxent b'rinite allerġika (li kienu jinkludu erba' studji fuq rinite allerġika staġjonali u żewġ studji f'pazjenti li kellhom ukoll l-ażżma).
English: Why has Azomyr been approved?
Maltese: Għaliex ġie approvat Azomyr?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr on 15 January 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Azomyr valida madwar l-Unjoni Ewropea kollha fil-15 ta' Jannar 2001.
English: For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Maltese: Għal tfal li l-età tagħhom tvarja bejn sitta u 11-il sena, id-doża hi ta' 2.5 mg darba kuljum, li tittieħed jew bħala 5 ml ta' soluzzjoni orali, jew bħala pillola ta' 2.5 mg li tinħall fil-ħalq.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Azomyr fis-serħan mis-sintomi assoċjati mar-rinite allerġika jew mal-urtikarja huma ikbar mir-riskji.
English: For the full list of all side effects reported with Azomyr, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Azomyr, ara l-Fuljett ta' Tagħrif.
English: How has Azomyr been studied?
Maltese: Kif ġie studjat Azomyr?
English: C/ Jorge Comín (médico pediatra), 3-bajos 46015 Valencia Spain
Maltese: PENSA PHARMA, S.A.U. C/ Jorge Comín (médico pediatra), 3-bajos 46015 Valencia Spain
English: FENOFIBRATO RANBAXY 160 mg comprimidos recubiertos con película EFG 160 mg Film-coated tablet Oral use
Maltese: FENOFIBRATO RANBAXY 160 mg comprimidos recubiertos con película EFG 160 mg
English: FENOFIBRATO PENSA 160 mg comprimidos recubiertos con película EFG 160 mg Film-coated tablet Oral use
Maltese: FENOFIBRATO PENSA 160 mg comprimidos recubiertos con película EFG
English: LABORATORIOS RANBAXY, S.L.
Maltese: LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: Lista ta` l-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi ta` l-awtorizzazzjoni għat tqegħid fis-suq fl-istati membri
English: Marketing authorisation holder
Maltese: Id-Detentur ta' lAwtorizzazzjoni għattqegħid fis-suq
English: • a bisphosphonate
Maltese: • bisphosphonate
English: Date of latest renewal: 4 April 2016
Maltese: Data tal-aħħar tiġdid: 4 ta' April 2016
English: 1 CI = Exact Confidence Interval
Maltese: 1 CI = Intervall ta' kunfidenza Eżatt
English: 4 Class effect
Maltese: 4 Effett tal-klassi
English: Proportion (%) (95% CI)1
Maltese: Proporzjoni (%) (CI ta' 95%) 1
English: • diarrhoea.
Maltese: • dijarea.
English: INFORMATION IN BRAILLE xgeva
Maltese: INFORMAZZJONI BIL-BRAILLE xgeva
English: N = number of subjects randomised
Maltese: N = numru ta' individwi randomised
English: Study 2**
Maltese: Studju 2**
English: Do not use XGEVA:
Maltese: Tużax XGEVA:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 1 single use vial EU/1/11/703/002 4 single use vials EU/1/11/703/003 3 single use vials
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/703/001 kunjett wieħed għall-użu ta' darba EU/1/11/703/002 4 kunjetti għall-użu ta' darba EU/1/11/703/003 3 kunjetti għall-użu ta' darba
English: Hypocalcaemia1, 2
Maltese: Ipokalċimija1, 2
English: Each 1.7 mL of solution contains 78 mg sorbitol (E420).
Maltese: Kull 1.7 mL ta' soluzzjoni fihom 78 mg sorbitol (E420).
English: Between weeks 9 and 49, median trough levels varied by less than 9%.
Maltese: Bejn ġimgħat 9 u 49, l-inqas livelli medjana varjaw b'inqas minn 9%.
English: Study 2 other solid tumours** or multiple myeloma
Maltese: Studju 2 tumuri solidi oħra** jew mjeloma multipla
English: Upon enrolment of 305 patients in studies 5 and 6 a retrospective independent review of radiographic imaging data was performed.
Maltese: Mar-reġistrazzjoni ta' 305 pazjenti fi studji 5 u 6 saret analiżi indipendenti retrospettiva ta' data ta' immaġini radjugrafiċi.
English: Osteonecrosis of the jaw (ONJ)
Maltese: Osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw)
English: • low phosphate levels in the blood (hypophosphataemia),
Maltese: • livelli baxxi ta' fosfat fid-demm (ipofosfatimija),
English: XGEVA contains sorbitol
Maltese: XGEVA fih sorbitol
English: Study 3*
Maltese: Studju 3*
English: The overall incidence of clinically significant hypocalcaemia was 9%.
Maltese: L-inċidenza globali ta' ipokalċimija klinikament sinifikanti kienet 9%.
English: The number of patients across both study arms with ISS stage I, stage II, and stage III at diagnosis were 32.4%, 38.2%, and 29.3%, respectively.
Maltese: In-numru ta' pazjenti tul iż-żewġ gruppi tal-istudju b'ISS stadju I, stadju II, u stadju III fid-dijanjosi kien 32.4%, 38.2% u 29.3%, rispettivament.
English: Study 3 prostate cancer
Maltese: Studju 3 kanċer tal-prostata
English: Study 1*
Maltese: Studju 1*
English: Examples of clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (including coma) (see section 4.4).
Maltese: Eżempji ta' manifestazzjonijiet kliniċi ta' ipokalċimija sintomatika severa inkludew titwil tal-intervall QT, tetanja, aċċessjonijiet u stat mentali mibdul (inkluż koma) (ara sezzjoni 4.4).
English: Overall safety profile is consistent in all approved indications for XGEVA.
Maltese: Il-profil ġenerali tas-sigurtà huwa konsistenti fl-indikazzjonijiet approvati kollha għal XGEVA.
English: N = Number of subjects randomised * = Statistically significant for superiority; ** = Statistically significant for non-inferiority
Maltese: N = Numru ta' individwi randomised * = Statistikament sinifikanti għal superjorità; ** = Statistikament sinifikanti għal nuqqas ta' inferjorità
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 13 ta' Lulju 2011
English: The median time to surgery was 261 days.
Maltese: Iż-żmien medjan għall-kirurġija kien ta' 261 jum.
English: Density/Size4
Maltese: Densità/Daqs4
English: The median time to ONJ was 20.6 months (range: 4 - 53).
Maltese: Iż-żmien medjan sa ONJ kien ta' 20.6 xhur (firxa: 4 - 53).
English: • cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Maltese: • kanċer, kondizzjonijiet ko-morbużi (eż. anemija, disturbi fit-tagħqid tad-demm, infezzjoni), tipjip.
English: In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms.
Maltese: B'mod ġenerali, antikorpi monoklonali mhux eliminati permezz ta' mekkaniżmi metaboliċi epatiċi.
English: 1 See section Description of selected adverse reactions 2 See section Other special populations 3 See section 4.4
Maltese: 1 Ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula 2 Ara s-sezzjoni Popolazzjonijiet speċjali oħra 3 Ara s-sezzjoni 4.4
English: XGEVA contains sodium
Maltese: XGEVA fih sodium
English: A population pharmacokinetic analysis did not indicate clinically significant changes in the systemic exposure of denosumab at steady-state with respect to age (18 to 87 years), race/ethnicity (Blacks, Hispanics, Asians and Caucasians explored), gender or solid tumour types or patients with multiple myeloma.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ma indikatx bidliet klinikament sinifikanti fl-esponiment sistemiku ta' denosumab fi stat fiss rigward l-età (18 sa 87 sena), razza/etniċità (esplorati Suwed, Ispaniċi, Asjatiċi u Kawkasi), sess jew tipi ta' tumuri solidi jew pazjenti b'mijeloma multipla.
English: No data are available on the effect of denosumab on human fertility.
Maltese: M'hemmx data disponibbli dwar l-effett ta' denosumab fuq il-fertilità umana.
English: The median time to response was 3.1 months (95% CI: 2.89, 3.65).
Maltese: Iż-żmien medjan għal rispons kien ta' 3.1 xhur (CI ta' 95%: 2.89, 3.65).
English: Within these active-controlled clinical trials, safety was evaluated in 5,931 patients.
Maltese: F'dawn ilprovi kliniċi kkontrollati bl-attiv, is-sigurtà ġiet evalwata f'5,931 pazjent.
English: The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid, respectively.
Maltese: L-inċidenza kumulattiva f'sena kienet ta' 1.1% għal denosumab u 0.6% għal zoledronic acid, rispettivament.
English: The median time to ONJ was 18.7 months (range: 1 - 44).
Maltese: Iż-żmien medjan għal ONJ kien ta' 18.7 xhur (firxa: 1 - 44).
English: First and subsequent SRE Mean number of events/patient Rate ratio (95% CI) Skeletal morbidity rate per year
Maltese: L-ewwel SRE u SRE sussegwenti Numru medju ta' avvenimenti/pazjent Proporzjon tar-rata (CI ta' 95%) Rata ta' morbożità skeletrika kull sena
English: Adolescent primates dosed with denosumab at 2.7 and 15 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Maltese: Primati adolexxenti ddożati b'denosumab b'2.7 u 15-il darba (doża ta' 10 u 50 mg/kg) l-esponiment kliniku kellhom pjanċi tat-tkabbir mhux normali.
English: New primary malignancy
Maltese: Tumur malinn primarju ġdid
English: Overall survival was longer for XGEVA in non-small cell lung cancer (hazard ratio [95% CI] of 0.79 [0.65, 0.95]; n = 702) and longer for zoledronic acid in multiple myeloma (hazard ratio [95% CI] of 2.26 [1.13, 4.50]; n = 180) and similar between XGEVA and zoledronic acid in other tumour types (hazard ratio [95% CI] of 1.08 (0.90, 1.30); n = 894).
Maltese: Is-sopravivenza globali kienet itwal għal XGEVA fil-kanċer tal-pulmun taċ-ċellula mhux żgħira (proporzjon ta' periklu [CI ta' 95%] ta' 0.79 [0.65, 0.95]; n = 702) u itwal għal zoledronic acid f'mjeloma multipla (proporzjon ta' periklu [CI ta' 95%] ta' 2.26 [1.13, 4.50]; n = 180) u kienet simili bejn XGEVA u zoledronic acid f'tipi oħra ta' tumuri (proporzjon ta' periklu [CI ta' 95%] ta' 1.08 (0.90, 1.30); n = 894).
English: Based on these limited data, the adverse event profile appeared to be similar to adults.
Maltese: Ibbażat fuq din id-data limitata, il-profil ta' avvenimenti avversi deher li huwa simili għall-adulti.
English: Musculoskeletal pain1
Maltese: Uġigħ muskolu-skeletriku1
English: The following convention has been used for the classification of the adverse reactions based on incidence rates in four phase III, two phase II clinical studies and post-marketing experience (see table 1): 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) and not known (cannot be estimated from the available data.
Maltese: II u waqt esperjenza ta' wara t-tqegħid fis-suq (ara tabella 1): 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Osteonecrosis of the external auditory canal3,4
Maltese: Osteonekrosi tal-kanal estern tas-smigħ3,4
English: In subjects with multiple myeloma who received 120 mg every 4 weeks, median trough levels varied by less than 8% between months 6 and 12.
Maltese: F'individwi b'mijeloma multipla li rċivew 120 mg kull 4 ġimgħat, livelli minimi medjana varjaw b'inqas minn 8% bejn xhur 6 u 12.
English: Calcium and vitamin D supplementation
Maltese: Supplimentazzjoni ta' kalċju u vitamina D
English: Hypocalcaemia can be severe and symptomatic (see section 4.8 - description of selected adverse reactions).
Maltese: Ipokalċimija tista' tkun severa u sintomatika (ara sezzjoni 4.8 - deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: • Additional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskju
English: XGEVA 120 mg solution for injection denosumab
Maltese: XGEVA 120 mg injezzjoni denosumab
English: Severe, untreated hypocalcaemia (see section 4.4).
Maltese: Ipokalċimija severa u mhux ittrattata (ara sezzjoni 4.4).
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' denosumab ma ġewx studjati f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: In clinical studies, neutralising antibodies have not been observed for denosumab.
Maltese: Fi studji kliniċi, ma kinux osservati antikorpi newtralizzanti għal denosumab.
English: In studies of denosumab (60 mg, n = 55 and 120 mg, n = 32) in patients without advanced cancer but with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab; thus dose adjustment for renal impairment is not required.
Maltese: Fi studji ta'denosumab (60 mg, n = 55 u 120 mg, n = 32) f'pazjenti mingħajr kanċer avvanzat iżda bi gradi differenti ta' funzjoni renali, inkluż pazjenti fuq dijalisi, il-grad ta' indeboliment renali ma kellu l-ebda effett fuq il-farmakokinetika ta' denosumab; għalhekk aġġustament tad-doża għal indeboliment renali ma jkunx meħtieġ.
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Maltese: Ilma għall-injezzjonjiet * Baffer tal-acetate huwa ffurmat billi jitħallat acetic acid ma' sodium hydroxide
English: The median number of doses administered was 16 for XGEVA and 15 for zoledronic acid.
Maltese: In-numru medjan ta' dożi mogħtija kien ta' 16 għal XGEVA u 15 għal zoledronic acid.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.7 mL
Maltese: INDIVIDWALI 1.7 mL
English: Hypocalcaemia was reported in 16.9% of patients treated with XGEVA and 12.4% of patients treated with zoledronic acid.
Maltese: L-ipokalċimija kienet irrappurtata f'16.9% tal-pazjenti ttrattati b'XGEVA u fi 12.4% tal-pazjenti ttrattati b'zoledronic acid.
English: Of the 35 patients included in the efficacy analysis, 85.7% (95% CI: 69.7, 95.2) had a treatment response to XGEVA.
Maltese: 7% (CI ta' 95%: 69.7, 95.2) kellhom rispons għal trattament ta' XGEVA.
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarjiet rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000):
English: Across both study arms, 54.5% of patients intended to undergo autologous PBSC transplantation, 95.8% patients utilised/planned to utilise a novel anti-myeloma agent (novel therapies include bortezomib, lenalidomide, or thalidomide) in first-line therapy, and 60.7% of patients had a previous SRE.
Maltese: Tul iż-żewġ gruppi tal-istudju, 54.5% tal-pazjenti kellhom jagħmlu trapjant awtologu ta' PBSC, 95.8% tal-pazjenti użaw/kien ippjanat li jużaw sustanza ġdida kontra l-mijeloma (terapiji ġodda jinkludu bortezomib, lenalidomide, jew thalidomide) fit-terapija tal-ewwel għazla, u 60.7% tal-pazjenti kellhom SRE preċedenti.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases - other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Maltese: Mediċini għat-trattament ta' mard fl-għadam - mediċini oħra li għandhom effett fuq l-istruttura u l-mineralizzazzjoni tal-għadam, Kodiċi ATC: M05BX04