FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Maltese: Effikaċja klinika fil-kura tal-Marda ta' Paget tal-għadam Zoledronic acid kienet studjata f'pazjenti rġiel u nisa ta' etajiet ‘l fuq minn 30 sena li kellhom primarjament marda ta' Paget tal-għadam minn ħafifa sa moderata (il-medja tal-livell ta' alkaline phosphatase fis-serum kienet 2.6-3.0 darbiet l-ogħla limitu tal-medda tar-referenza normali skont l-età fil-ħin li ddaħħlu għall-istudju) konfermata b'evidenza radjugrafika.
English: Norge Teva Norway AS
Maltese: Deutschland TEVA GmbH
English: You may eat normally on the day you are treated with Zoledronic acid Teva Pharma.
Maltese: Tista' tiekol normali dakinhar meta qed tingħata t-trattament b'Zoledronic acid Teva Pharma.
English: Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid compared to placebo.
Maltese: Analiżi tat-tomografija mikrokomputata (μCT) wriet żieda fil-volum trabekulari talgħadam u priżervazzjoni tal-arkitettura trabekulari tal-għadam f'pazjenti kkurati b'Zoledronic acid meta mqabbla ma' plaċebo.
English: While being treated with Zoledronic acid Teva Pharma, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt it-trattament Zoledronic acid Teva Pharma, għandek iżżomm iġjene tajba fil-ħalq (inkluż billi taħsel snienek regolarment) u tagħmel check-ups tas-snien regolari.
English: Nausea, vomiting, diarrhoea
Maltese: Dardir, rimettar, dijarea
English: Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
Maltese: Kull ml ta' soluzzjoni fih 0.05 mg Zoledronic acid (bħala monohydrate).
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Maltese: Ġew irrappurtati każijiet rari ta' insuffiċjenza renali li teħtieġ dijaliżi u każijiet rari li kellhom riżultat fatali f'pazjenti li diġà jkollhom disfunzjoni tal-kliewi jew xi fatturi oħra ta' riskju fosthom l-età avvanzata, prodotti mediċinali nefrotossiċi konkomitanti, terapija djuretika konkomitanti jew deidrazzjoni fil-perjodu ta' wara linfużjoni (ara l-effetti skont il-klassi f'sezzjonijiet 4.4 u 4.8)
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Zoledronic acid Teva Pharma (see section 4.3).
Maltese: Pazjenti li jkollhom ipokalċimija minn qabel, għandhom ikunu kkurati b'ammonti xierqa ta' kalċju u vitamina D qabel ma tinbeda t-terapija b'Zoledronic acid Teva Pharma (ara sezzjoni 4.3).
English: ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8).
Maltese: Osteonekrożi tax-xedaq (ONJ) Kienet irrapportata ONJ f'kuntest wara t-tqegħid fis-suq f'pazjenti li ngħataw zoledronic acid għall osteoporożi (ara sezzjoni 4.8).
English: Solution for infusion 1 bag of 100 ml.
Maltese: Soluzzjoni għall-infużjoni Borża waħda ta' 100 mL.
English: The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) lowtrauma hip fracture who were followed for an average of 2 years on study treatment.
Maltese: L-inċidenza ta' ksur kliniku, inkluż ksur vertebrali, mhux vertebrali u tal-ġenbejn, ġiet evalwata f'2,127 raġel u mara li kellhom bejn 50 u 95 sena (età medja ta' 74.5 sena) bi ksur riċenti (fi żmien 90 jum) tal-ġenbejn bi trawma żgħira li kienu segwiti għal medja ta' sentejn fuq il-kura ta' studju.
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles
Maltese: EU/1/12/772/003 pakkett b'ħafna b'5 boroż EU/1/12/772/004 pakkett b'ħafna b'10 boroż
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid
Maltese: Zoledronic acid Teva Pharma 5 mg soluzzjoni għall-infużjoni Zoledronic acid
English: The following should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Maltese: Dawn li ġejjin għandhom jiġu kkunsidrati fl-evalwazzjoni tar-riskju ta' pazjent li jiżviluppa ONJ: - Il-potenza tal-prodott mediċinali li jinibixxi risorbiment tal-għadam (riskju ogħla għal komposti potenti ħafna), ir-rotta tal-amministrazzjoni (riskju ogħla għal amministrazzjoni parenteli) u d doża kumulattiva tat-terapija ta' risorbiment tal-għadam.
English: It is an inhibitor of osteoclast-mediated bone resorption.
Maltese: Jiġi fi flixkun ċar tal-plastik.
English: Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Maltese: Disturbi oħrajn fil-metaboliżmu tal-minerali għandhom ikunu kkurati wkoll b'mod effettiv (eż. tnaqqis firriserva tal-paratirojde, malassorbiment tal-kalċju mill-imsaren).
English: In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid and one patient treated with placebo.
Maltese: Fi prova klinika kbira, minn 7,736 pazjent, l-osteonekrożi tax-xedaq kienet irrappurtata f'pazjent wieħed ikkurat b'Zoledronic acid u f'pazjent wieħed ikkurat bi plaċebo.
English: C-reactive protein increased Uncommon Blood calcium decreased
Maltese: pollakijurja, proteinurja Indeboliment renali.
English: Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Maltese: Uġigħ sever u kultant dgħufija fl-għadam, il-ġogi u/jew il-muskoli kien irrappurtat b'mod mhux frekwenti f'pazjenti fuq bisphosphonates, inkluża Zoledronic acid (ara sezzjoni 4.8).
English: Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely.
Maltese: Għaldaqstant, nuqqas ta' qbil minħabba qlugħ ta' mediċini li jintrabtu ħafna mal-proteini mhuwiex probabbli.
English: Other medicines and Zoledronic acid Teva Pharma
Maltese: Mediċini oħra u Zoledronic acid Teva Pharma
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bags zoledronic acid
Maltese: Zoledronic acid Teva Pharma 5 mg soluzzjoni għall-infużjoni f'boroż Zoledronic acid
English: Caution is indicated when Zoledronic acid Teva Pharma is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Maltese: Għandha tingħata attenzjoni meta Zoledronic acid Teva Pharma tingħata ma' prodotti mediċinali li jista' jkollhom impatt sinifikanti fuq il-funzjoni renali (eż. aminoglycosides jew dijuretiċi li jikkawżaw deidrazzjoni) (ara sezzjoni 4.4).
English: After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Maltese: Intwera li hemm stabbilità kimika u fiżika waqt l-użu ta' 24 siegħa bejn 2 u 8°C u 25°C.
English: How to store Zoledronic acid Teva Pharma
Maltese: Kif tingħata Zoledronic acid Teva Pharma
English: Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Maltese: Osteoporożi hija marda fejn l-għadam jirqaq u jiddgħajjef u hija komuni f'nisa wara l-menopawża, iżda tista' sseħħ ukoll fl-irġiel.
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome
Maltese: Tabella 4 Paraguni bejn it-trattamenti tal-inċidenza ta' varjabbli ta' ksur kliniku ewlieni Eżitu
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Pharma, as directed by your healthcare provider.
Maltese: Importanti li tixrob mill-inqas 2 tazzi fluwidu (bħal ilma), fi żmien ftit sigħat qabel ma tieħu Zoledronic acid Teva Pharma, kif indikat minn min qed jiddireġik.
English: In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was noninferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
Maltese: Fi studju ieħor fuq l-irġiel (studju CZOL446M2308), infużjoni darba f'sena ta' Zoledronic acid ma kinetx inferjuri għal alendronate kull ġimgħa għall-bidla medja fil-BMD tal-ispina lumbari wara 24 xahar meta mqabbel mal-linja bażi.
English: In patients with a recent lowtrauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
Maltese: F'pazjenti bi ksur riċenti tal-ġenbejn bi trawma żgħira, hija rakkomandata doża tal-bidu ta' 50 000 sa 125 000 IU ta' vitamina D li tingħata mill-ħalq jew ġol-muskolu qabel l-ewwel infużjoni ta' zoledronic acid.
English: It comes in a polyolefin/styreneethylene-butylene (SEB) foil bag with a foil over pouch.
Maltese: Jiġi f'borża tal-fojl ta' 100 ml magħmula minn polyolefin/styrene-ethylene-butylene (SEB) f'pouch miksija bil-fojl.
English: The use of Zoledronic acid Teva Pharma in children and adolescents has not been studied.
Maltese: L-użu ta' Zoledronic acid Teva Pharma fi tfal u adolexxenti ma kienx studjat.
English: Each bag contains 100 ml solution.
Maltese: Kull borża fiha 100 ml ta' soluzzjoni.
English: Talk to your doctor, pharmacist or nurse before you are given Zoledronic acid Teva Pharma: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic acid Teva Pharma (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
Maltese: Kellem lit-tabib, l-ispiżjar jew l-infermier tiegħek qabel tieħu Zoledronic acid Teva Pharma: - jekk qed tingħata kura b'xi mediċina oħra li fiha zoledronic acid, li huwa wkoll is-sustanza attiva ta' Zoledronic acid Teva Pharma (zoledronic acid jintuża f'pazjenti adulti b'ċerti tipi ta' kanċers biex jipprevjeni kumplikazzjonijiet fl-għadam jew biex inaqqas l-ammont ta' kalċju). - jekk għandek problema fil-kliewi jew xi darba kellek problema fil-kliewi.
English: - After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Maltese: - Wara li tiftaħ il-flixkun, intwera li hemm stabbilità kimika u fiżika waqt l-użu ta' 24 siegħa bejn 2 u 8°C, u 25°C.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Maltese: Kull borża b'100 ml ta' soluzzjoni fiha 5 mg zoledronic acid anhydrous (bħala monoidrat).
English: If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic acid Teva Pharma.
Maltese: Jekk qed tieħu trattament tas-snien jew wasalt biex tagħmel operazzjoni dentali (eż. qlugħ ta' snien), għarraf lit-tabib tiegħek dwar it-trattament tas-snien li qed tieħu u għid lid-dentist tiegħek li qed tingħata trattament Zoledronic acid Teva Pharma.
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Maltese: Disfunzjoni renali kienet osservata wara li ngħata zoledronic acid, l-aktar f'pazjenti li kellhom disfunzjoni talkliewi minn qabel jew li kellhom xi fatturi ta' riskji oħrajn (eż. età avvanzata, pazjenti tal-onkoloġija fuq kimoterapija, l-użu konkomitanti ta' prodotti mediċinali nefrotossiċi fl-istess waqt, terapija djuretika konkomitanti, deidrazzjoni severa), bil-parti l-kbira tagħhom jirċievu doża ta' 4 mg kull 3-4 ġimgħat, iżda dehret f'pazjenti wara doża waħda.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu..
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years
Maltese: Tabella 3 Tqabbil bejn il-kuri tal-inċidenza ta' varjanti kliniċi ewlenin fuq 3 snin Riżultat
English: The use of Zoledronic acid Teva Pharma in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Maltese: L-użu ta' Zoledronic Acid Teva Pharma f'pazjenti b'indeboliment renali sever (tneħħija tal-kreatinina < 35 ml/min) huwa kontraindikat minħabba riskju akbar ta' insuffiċjenza renali f'din ilpopolazzjoni.
English: proteinuria
Maltese: Pożoloġija
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Maltese: • Pazjenti, speċjalment dawk anzjani u dawk li jkunu qed jirċievu terapija djuretika, għandhom jiġu idratati kif xieraq qabel ma jingħataw Zoledronic acid Teva Pharma.
English: • Once-yearly dosing regime
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zoledronic acid fit-tfal u l-adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Maltese: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél:
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis.
Maltese: Effett sekondarju msejjaħ osteonekrożi tax-xedaq (ONJ) (ħsara tal-għadam fix-xedaq) kien irrapportat fil-kuntest ta' wara t-tqegħid fis-suq f'pazjenti li ngħataw kura b' Zoledronic acid Teva Pharma għallosteoporożi.
English: Zoledronic acid Teva Pharma contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml; i.e. essentially “sodium -free.”
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodju (23 mg) f'kull 100 ml; jiġifieri essenzjalment “mingħajr sodju”.
English: reduction in fracture incidence % (CI)
Maltese: Tnaqqis relattiv flinċidenza tal-fratturi % (CI)
English: Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma.
Maltese: Kienu rrapportati każijiet ta' ONJ filkuntest ta' wara t-tqegħid fis-suq għal Zoledronic acid Teva Pharma.
English: Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Zoledronic acid Teva Pharma (see section 4.8).
Maltese: Uġigħ sever u kultant dgħufija fl-għadam, il-ġogi u/jew il-muskoli kien irrappurtat b'mod mhux frekwenti f'pazjenti fuq bisphosphonates, inkluża Zoledronic acid Teva Pharma (ara sezzjoni 4.8).
English: Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Maltese: Tbatija talħlas kienet osservata bl-aktar doża baxxa (0.01 mg/kg piż tal-ġisem) eżaminata fil-firien.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji bil-prodott mediċinali ta' referenza zoledronic acid f'kull sett tal-popolazzjoni pedjatrika fil-marda talgħadam ta' Paget, osteoporożi fin-nisa ta' wara l-menopawża li jkunu f'riskju ogħla ta' ksur, osteoporożi fl-irġiel f'riskju ogħla ta' ksur u fil-prevenzjoni ta' ksur kliniku wara ksur tal-ġenbejn flirġiel u fin-nisa (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Re-treatment consists of an additional intravenous infusion of 5 mg Zoledronic acid Teva Pharma after an interval of one year or longer from initial treatment in patients who have relapsed.
Maltese: Trattament mill-ġdid jikkonsisti f'infużjoni oħra minn ġol-vina ta' 5 mg Zoledronic acid Teva Pharma wara intervall ta' sena jew aktar minn meta nbeda t-trattament f'pazjenti li kellhom rikaduta.
English: The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma.
Maltese: Id-doża rrakkomandata hija ta' infużjoni waħda fil-vini ta' 5 mg Zoledronic acid Teva Pharma.
English: What Zoledronic acid Teva Pharma is and what it is used for What you need to know before you are given Zoledronic acid Teva Pharma How Zoledronic acid Teva Pharma is given
Maltese: Kif jidher Zoledronic acid Teva Pharma u l-kontenut tal-pakkett Zoledronic acid Teva Pharma hija soluzzjoni ċara mingħajr kulur.
English: Not known** Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Maltese: Reazzjonijiet ta' sensittività eċċessiva li jinkludu każijiet rari ta' tidjiq tal-bronki, urtikarja u anġjoedima, u każijiet rari ħafna ta' reazzjoni anafilattika/xokk
English: The incidence of post-dose symptoms occuring within the first three days after administration of Zoledronic acid Teva Pharma can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic acid Teva Pharma administration.
Maltese: Il-parti l-kbira tal-effetti sekondarji, bħal deni u dehxiet, uġigħ fil-muskoli jew ġogi, u uġigħ ta' ras, iseħħu fl-ewwel tlett ijiem wara d-doża ta' Zoledronic acid Teva Pharma .
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/772/003 multipack with 5 bags
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/772/003 pakkett b'ħafna b'5 boroż
English: Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Maltese: Mill-153 pazjent ikkurati b'Zoledronic acid u 115 pazjenti kkurati b'risedronate li ddaħħlu fl-istudju estiż ta' osservazzjoni, wara perjodu medju ta' follow-up ta' 3.8 snin minn meta ngħataw id-dożaġġi, il-proporzjon ta' pazjenti li temmew il-Perjodu Estiż ta' Osservazzjoni minħabba l-ħtieġa għal trattament mill-ġdid (ġudizzju kliniku) kien ogħla għal risedronate (48 pazjent, jew 41.7%) meta mqabbel ma' zoledronic acid (11-il pazjent, jew 7.2%).
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2).
Maltese: Fil-prova għall-prevenzjoni ta' ksur kliniku wara ksur riċenti fil-ġenbejn, il-livelli ta' vitamina D ma tkejlux b'mod regolari iżda l-maġġoranza tal-pazjenti ngħataw doża tal-bidu ta' vitamina D qabel l-għoti ta' zoledronic acid (ara sezzjoni 4.2).
English: Each bottle contains 5 mg zoledronic acid (as monohydrate).
Maltese: Kull flixkun fih 5 mg zoledronic acid (bħala monohydrate).
English: The full EPAR for Kyntheum can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Kyntheum, brodalumab, is a monoclonal antibody, a protein designed to block the activity of certain substances called interleukins 17 (A, F and A/F), which are messengers in the body's immune system (the body's natural defences).
Maltese: Is-sustanza attiva f'Kyntheum, brodalumab, hija antikorp monoklonali, proteina mfassla biex timbolokka l-attività ta' ċerti sustanzi msejħin interleukins 17 (A, F u A/F), li huma messaġġiera fissistema immuni tal-ġisem (id-difiżi naturali tal-ġisem).
English: Kyntheum contains the active substance brodalumab.
Maltese: Kyntheum fih is-sustanza attiva brodalumab.
English: The doctor may decide to stop treatment if the condition does not improve after 12 to 16 weeks.
Maltese: It-tabib jista' jiddeċiedi li jwaqqaf il-kura jekk il-kondizzjoni ma titjiebx wara 12 sa 16-il ġimgħa.
English: Why is Kyntheum approved?
Maltese: Għaliex ġie approvat Kyntheum?
English: Interleukins 17 are involved in the process of inflammation that causes plaque psoriasis.
Maltese: L-interleukins 17 huma involuti fil-proċess talinfjammazzjoni li tikkawża psorijażi tal-plakka.
English: Other information about Kyntheum
Maltese: Informazzjoni oħra dwar Kyntheum
English: This is a summary of the European public assessment report (EPAR) for Kyntheum.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Kyntheum.
English: Side effects are similar to those of other medicines that target interleukin molecules.
Maltese: L-effetti sekondarji huma simili għal dawk ta' mediċini oħra li jimmiraw il-molekuli interleukin.
English: Looking at the results of the 3 studies together, 85% of patients treated with Kyntheum obtained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks.
Maltese: Meta wieħed iħares lejn ir-riżultati ta' 3 studji flimkien, 85 % tal-pazjenti kkurati b'Kyntheum kisbu tnaqqis ta' 75 % fil-punteġġi PASI (kejl tas-severità tal-marda u ż-żona tal-ġilda affettwata) wara 12-il ġimgħa.
English: This compares with 6% of those given placebo and with 70% of patients given ustekinumab.
Maltese: Dan huwa mqabbel ma' 6 % ta' dawk mogħtija plaċebo u mas-70 % tal-pazjenti mogħtija ustekinumab.
English: Plaque psoriasis improved to a greater extent in patients treated with Kyntheum than with placebo (a dummy treatment) or with ustekinumab (another medicine for psoriasis that targets interleukin molecules).
Maltese: Il-psorjasi tal-plakka tjiebet b'mod iktar estensiv f'pazjenti kkurati b'Kyntheum milli bil-plaċebo (kura finta) jew b'ustekinumab (mediċina oħra użata għall-psorjasi li għandha fil-mira l-molekuli interleukin).
English: What are the risks associated with Kyntheum?
Maltese: X'inhuma r-riskji assoċjati ma' Kyntheum?
English: The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks.
Maltese: Id-doża rakkomandata hija 210 mg li tingħata darba f'ġimgħa fl-ewwel 3 ġimgħat u mbagħad kull ħmistax.
English: By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease.
Maltese: Billi jimblokka l-azzjoni tas-sustanzi ta' interleukin 17, brodalumab inaqqas l-infjammazzjoni u s-sintomi assoċjati mal-marda.